ABOUT-Consulting, LLC

Houston, TX - Field Applications Engineer

2011-11-22T10:04:00.000-08:00

Job Description:

This individual will be responsible for supporting the company's OEM customers designing silicon devices and systems into their products
The ideal candidate should have a development background in the fields of board design, firmware development, low level device driver development or application software development
Responsibilities include technical management of accounts; participating in the project life cycle to include definition, design, software porting, reviews, bring-up and ongoing support; delegating issues to the company's engineering and drive for solution; preparing and delivering technical training/presentations; and participating in pre-sales activities

Requirements:

The candidate must show good overall understanding of system level issues and be familiar with high-speed networking technologies and protocols (particularly 10/40Gigabit Ethernet, InfiniBand, Fibre Channel)
BSEE/BSCS or higher
3+ years HW/SW development experience or highly technical support experience
Knowledge of networking protocols, including layers 2, 3 and 4
Independent. Self-motivated. Dedicated.
Excellent communication skills
Up to 20% travel required

Advantages:

Knowledge in InfiniBand networking spec and protocol stack
Knowledge in C, C++ and scripting languages (BASH, Perl, Python)
Understanding of Linux/Windows/VMware/Solaris internals

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Sunnyvale, CA; Chicago, IL; Edison, NJ; Dallas, TX - Field Support Engineer

2011-11-21T09:37:00.000-08:00

Job Description:

The Field Support Engineer (FSE) is an integral part of the company's Support Organization
The FSE is responsible for the deployment of current and future products at customer sites
The FSE is also responsible for the on-site and remote support of issues raised by customers
An FSE is a results driven person capable of working independently and within a team to resolve time critical deployment and production issues
Contributes significantly to customer satisfaction
Interfaces with the customer and project manager to complete assigned tasks
Responsible for opening lines of communication, monitors customer problems, and ensures effective resolution
Travel requirement is at about 20-30%
Provide “on-call” service periodically

Requirements:

Highly Knowledgeable in TCP/IP networking preferably at an Expert level
Highly experienced in troubleshooting network issues using a Sniffer
Familiar with the common Internet protocols at the packet and flow analysis level, such as : HTTP, FTP, RTSP, SSH, PKI, RTSP
Familiar in mobile network technologies including L3-7 switching and load balancing, redundancy (A/P, A/A) and high performance systems
Proficient in UNIX/Linux System Administration, a must
Knowledgeable in customer support processes, tooling and troubleshooting
Knowledge of common open source software
Knowledge of application servers, Weblogic/Jboss is an advantage
Knowledge of Oracle and/or MySQL administration is an advantage
Knowledge of IBM blade center technology and F5 load balancers is an advantage
Knowledgeable in Microsoft Office

Critical Competencies:

Customer Satisfaction

Contributes significantly to customer satisfaction
Interfaces with the customer and project manager to complete assigned tasks
Responsible for opening lines of communication, monitors customer problems, and ensures effective resolution

Communication Skills

Communicate effectively with customers and peers
Produce high quality written documents, status reports and customer communications
Identify appropriate internal and/or external resources to solve problems
Contribute to regular internal and customer meetings
Effectively escalate through appropriate channels – “knows how to make things happen”

Education: 4 year technical degree, Computer Science preferred

Relevant Experience: 5+ years

An advantage will be given to candidates that worked for Venturi, Byte Mobile, F5 and Cisco

Wireless telecom experience is also an advantages

International work experience and cultural awareness is an advantage

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Skillman, NJ - Scientist I

2011-09-23T13:30:00.000-07:00

JOB DESCRIPTION

Provide required Technical Transfer support to execution of Korres Integration Project

Activities to include:

Evaluating Korres formulas and manufacturing processes and entering required information in Company's systems (Optiva – GSS – etc.)
Identify each product’s required stability testing, obtaining required samples to execute the testing and coordinate testing of the samples thru the Company's Stability Department
Identify required raw material qualification activities for Korres products and coordinate obtaining samples and testing to meet the requirements with Company's Supply Chain/RMC
Create all required Product, Process and Raw Materials specifications for the project
Interfacing with all required Company's Functional Groups to obtain required documentation for assembly and approval of APRs
Transfer of new products-processes-test methods

QUALIFICATIONS:

0-3 years of experience working in a Scientific Lab
Prefers recent ChemE/Chemistry grads (spring/ summer 2011 grads ideal)

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Wilmington, DE - Health Econ and Outcomes Research Scientist

2011-09-22T15:52:00.000-07:00

JOB DESCRIPTION

Health Economics & Outcomes Research Scientist
Description: Role Holder will have responsibility to design and implement innovative Health Economic and/or Outcomes Research activities and produce scientific evidence to optimize price and value proposition
The role holder will assist communication efforts of value proposition and evidence to achieve maximal commercial success of products throughout their life cycle
The role holder will have in-depth, specialist knowledge of Health Economics and Outcomes Research (HE & OR) and its application to pharmaceutical development throughout development process

RESPONSIBILITIES:

Evaluate and analyze information and generate high quality health economics and/or outcomes research input to the product profile and claims and value demonstration plan
Proactively and independently contribute to research planning process and resolution of complex issues, which may impact market access decisions and evidence for product
Member of the Value Demonstration Work Stream if applicable
Interact with cross-functional team members at a project level
Supports Clinical Project Team (CPT)
Manage HE & OR activities as designated by HE & OR team leader
Assist study team personnel and associates in patient reported outcome instrument development and/or administration and or model development
Identifies external HE & OR data sources and literature references
Prepares proposal requests for Health Economic and Outcomes Research work projects and manages selection process
Budgeting accountability for sub-projects within the health economic project team
Prepares technical presentations
Assists in writing preparations, references, and development of reimbursement/formulary documents
Prepares HE & OR data as background materials and registration pack for discussion with regulatory authorities
Advances knowledge about health economics and outcomes research and the impact of pharmaceutical product development
Advance expertise in health economics and outcomes research through presentations, publications
Adaptation of global core value documents, communication materials, publications for use with US decision makers and purchasers

REQUIREMENTS:

Ten years of relevant experience, five of the years in the pharmaceutical/medical industry
Bachelor’s degree in clinical, biological, or social sciences
Master’s degree in relevant field (outcomes research, health services research, epidemiology, health economics, health policy or related fields)
Doctoral degree in relevant field preferred
Two years previous project experience in Health Economics and/or Outcomes Research
Previous project management or personnel management preferred
In-depth specialist knowledge of Health Economics and/or Outcomes Research and its application to pharmaceutical development at an international level
Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages
Knowledge of international healthcare systems and their changing needs for health economic and patient-reported outcomes information
Strong knowledge of legal and regulatory environment influencing clinical development plans, labeling and promotional claims
Proactive application of therapeutic area and disease treatment knowledge
Able to implement projects including key stakeholders with high degree of autonomy
Excellent written and verbal communication skills
Requires high level of interactive communication including challenges to conceptual thinking as necessary
Communicate project plans to commercial stakeholders
Proven teamwork and collaboration skills
Well-developed cultural sensitivity
Effectively represents the company externally to key stakeholders

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Wilmington, DE - Business Analyst

2011-09-21T16:04:00.001-07:00

JOB DESCRIPTION:

This Business Analyst role will work with Operational Excellence and Compliance Business Relationship Managers (BRM) to capture business requirements relating to information security in the context of move towards more collaborative use of information within the company and with external partners and develop new policies and processes required to align the information security capability with business requirements
Information services is moving towards a risk-based approach to information security policies and standards
The BRMs, assisted by this role, will engage the business community in understanding the business imperatives that will drive company's changing approach to information security

RESPONSIBILITIES:

Collaborate with the BRMs, information security subject matter experts, legal and privacy subject matter experts, and various technical experts
Lead and participate in workshops to elicit business requirements
Engage existing information management projects and/or organizations
Communicate the purpose and goals of Policy and Governance Project and the Information Security Programme and help build organizational support through constructive dialog
Work with Subject Matter Experts in the areas of information security, solution architecture, legal and privacy, and other stakeholders to understand the impact of business requirements on policy and standards

REQUIREMENTS:

Detailed knowledge of Information Security frameworks (e.g. ISO72001) with a significant external perspective
Familiarity with SOX impact on business governance processes
Skills and knowledge in Business Analysis, Benefits Management, Requirements Management and an appreciation of Programme and Project Management
Effective marketing and communication skills to sell the project vision to staff at all levels of the target community
Ability to bring order to complex situations and retain a focus on the project s objectives
Knowledge or appreciation of change techniques (e.g. business process re-engineering)
Working knowledge of information security frameworks in particular ISO27001
Ability to work effectively with executives and individual contributors
Excellent written communication skills
Ability to clearly document existing business processes, perform analysis, make process change recommendations, and document proposed business process, policy, and governance changes
Sensitivity to the differences in the various geographic locations affected by information security policy, standards, and governance and ensures that these differences are analyzed in the context of overall business requirements
Understanding of the workings of a complex multi-national organization in an environment of increased externalization of information services and business process

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Wilmington, DE - Senior Project Manager

2011-09-20T16:50:00.000-07:00

JOB DESCRIPTION:

The Wave Project Manager manages the program delivery for the North American wave of countries implementing the HR outsourcing program
The role has oversight of the program ensuring each element of the projects is on-time, on-budget and in adherence with quality and compliance standards
The role has responsibility to coordinate with a global team items such as UAT planning, knowledge transfer workshops, cutover process and key user identification and training
This wave of implementation includes all SET areas across Canada and US including R&D, Operations and Commercial segments
The Wave Project Manager shapes the wave project plan and acts as a liaison between the global program team, local functions, third party outsourced vendor and business stakeholders to ensure that the global business blueprint is effectively translated into the an effective program
The Wave Project Manager will partner with the Wave s team members including SMEs from finance, HR and IT to track key deliverables and milestones across country plans
The role is accountable to manage the project environment and ensure the third party is following established contractual project management methods including ISPDM methodology

RESPONSIBILITIES:

Support the CTL and lead country project teams to deliver improvement, working in line with the Project Management Framework
At any point in time the job holder may be accountable for the delivery of a number of sub- projects which may be connected to form an integrated programme of work
Proactively propose project opportunities having identified opportunities for improvement and innovation
Be accountable to the Country Transition Lead for the delivery of assigned project activities based on the agreed scope, deliverables, value proposition and benefits of the project through to adoption as business as usual
Build trust based relationships with key customers and suppliers
Secure resources for relevant sub-projects ensuring that the plan is optimal and competitive in terms of time, quality and costs.
Provide expert advice on the use of project management tools and methods to the CTL
Drive the identification of potential areas of risk relating to the project and ensure implementation of contingency/mitigation activities, working with the NGA project manager to ensure risks are appropriately logged and managed
Drive the evolution of project plans and other key documents ensuring that project data are up to date and accurately reflect the agreed plan, in particular quality assuring the project plan developed by the NGA project manager

REQUIREMENTS:

College/university degree
Demonstrated skills in multi-disciplinary project management
Experience of effective working in a multi-cultural team
Planning experience with globally working teams, with virtual outsourcing arrangements including all phases of the project lifecycle including design, build, test and cutover
Proven experience working with 3rd party suppliers; strong negotiation skills
Proven ability to learn new information effectively

PREFERED EXPERIENCE:

HR experience with Work Force Planning, Organizational Mapping and Payroll (ideally in PeopleSoft and SAP)
Extensive project management experience with a history of delivering significant activities
Solutioning experience; able to have a thorough understanding of a product and skillful in facilitating teams to solve related challenges
Demonstrated good team leadership

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Piscataway, NJ - Project Coordinator

2011-09-20T16:46:00.000-07:00

REQUIREMENTS:

A minimum of a Bachelor's degree required
A minimum of 3 -5 years overall business experience is required
Strong analytical skills are required
The ability to manipulate & synthesize large amounts of data, conduct impact analysis and summarize results for recommendation is required
Strong verbal and written communication skills to consolidate information & present to business partners and senior management is required
Strong Project Management Skills, Organizational and Time Management Skills and ability to Innovate are required
Experience and proven understanding implications/consequences of data on downstream processes/systems required
Advanced knowledge of Excel (including Pivot Tables & V-Look ups) is required
Working knowledge of MS Word, PowerPoint, Outlook, and Access is required
Experience identifying required data points to support appropriate analysis/business need required
Previously demonstrated ability to work independently with appropriate balance, escalating any issues and challenges required

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Wilmington, DE - Regulatory Submission Associate

2011-09-20T16:45:00.000-07:00

JOB DESCRIPTION:

Compile and publish assigned regulatory submissions
Coordinate printing and distribution of those submissions to all concerned markets within agreed timeframes
Manage the associated submission and product life-cycle regulatory status information

RESPONSIBILITIES:

Effectively communicate submission format requirements to the submission team
Collect necessary information and requirements from the submission team
Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools
Manage assigned regulatory status information for assigned markets
Ensure printing and distribution of regulatory submissions, paper and electronic, to all concerned markets, as required
Analyze submissions, track and record life-cycle information in accordance with standards
Perform searches on submission life-cycle information, as required
Take responsibility for and ensure regulatory submissions meet all mandatory health authority validation requirements
Participate on project teams (e.g., skill work, standards, or harmonization)
Participate on SMG working teams
Seek advice in and share best practices within SMG
The Job Holder has a responsibility to comply with, or be aware of (as appropriate) all relevant policies and cross-functional procedures

INTERNAL AND EXTERNAL CONTACTS/ CUSTOMERS:

Global Regulatory Leads (GRLs)
Other R&D functions (Clinical, Safety Assessment)
Operations (CMC post approval)
Marketing Companies
Health Authorities

REQUIREMENTS:

University degree or relevant equivalent experience
Basic knowledge of information management and document management
Technical orientation, attention to detail
Good written and verbal communication skills

PREFERED BACKGROUND:

Basic knowledge of the drug development process, product life-cycle, and contents/formatting of regulatory submissions
General understanding of other functions
Knowledge of submission compilation, publishing, approval information processes, tools and standards

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Piscataway, NJ - Project Manager I

2011-09-20T16:42:00.001-07:00

JOB DESCRIPTION

Oversees a group of individuals, tracks progress against the project plan and provides feedback and suggestions for process improvements
Understands all vital aspects of the particular project
Ensures all team members understand the scope of the project and their individually responsibilities
Works with project lead to drive outcome and suggests changes or redirection if necessary
Documents progress and best practice with a focus on data quality and process efficiency
Ensures issues are captured, tracked and resolved in a timely fashion
Establishes timelines of what needs to be completed by what date
Communicates relevant information to all team members such as schedule dates and/or changes in the project requirements
Comfortable learning new data management tools
Also has a portion of the project output allocated to him/herself
Able to interpret and apply pre-defined criteria to case by case scenarios

REQUIREMENTS:

Strong critical thinking and problem solving skills to assist in the development of best practices
Strong written and verbal communication skills required
The ability to quickly assimilates and digests information and understands priorities
Excellent computer skills (Excel, Word, PowerPoint, SharePoint)
Exceptional interpersonal, communication and organizational skills

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Morris Plain, NJ - Copy Development Project Manager

2011-09-20T16:41:00.000-07:00

JOB DESCRIPTION:

The Copy Development Project Manager owns and drives the copy development and artwork approval processes for all new products, advertising, promotions, educational materials, websites and public relations programs
The primary responsibility of this position is managing the copy development and artwork approvals for packaging, advertising, promotional and educational materials, (written, spoken or electronic form) distributed to consumers, professionals or the trade for Johnson & Johnson Inc.
This position will be located in Morris Plains, NJ
Involves a minimum of 10% domestic travel

REQUIREMENTS:

A minimum Bachelor’s degree with 3-5 years of experience in consumer goods or healthcare artwork/copy development
Attention to detail and strong project management skills
Strong organizational skills and ability to work under aggressive timelines to meet strict deadlines
Ability to multitask and prioritize competing agendas
Strong computer skills; familiarity with online systems preferred
Excellent business collaboration/interpersonal skills
Ability to work independently with little or no supervision
Understanding of consumer goods or healthcare packaging requirements and regulations
Familiarity with all types of marketing communication vehicles is preferred
New Product Development, R&D and/or Regulatory Affairs experience is also desirable

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Wilmington, DE - Regional Monitor Lead

2011-09-20T16:37:00.000-07:00

JOB DESCRIPTION:

The Regional Monitor Lead provides regional monitoring expertise and oversight to Flexible Workforce Monitors and Internal Study Delivery Teams (SDTs)
Regional Monitor Lead is responsible for the delivery of monitoring for assigned programs, ensuring workforce monitors are resourced and project trained to meet deliverables
The Regional Monitor Lead establishes communications plans and field/site management while ensuring monitoring deliverables and milestones are met
The Regional Monitor Lead collaborates with internal Study Delivery team, site staff and = field based employees (i.e. External Scientific Affairs)
Regional Monitor Lead may also perform site visits to assess monitoring competencies and build site relationships

MAJOR RESPONSIBILITIES:

Clinical Study Design, Execution and deployment of resources to given therapy teams
Partners cross-functionally with internal Study Delivery Team members to develop timelines and milestones for clinical studies and communicate timelines to deployed Regional Monitors
Assists internal Study Delivery Team in the recruitment and selection of investigators
Participates in the development and communication of US patient recruitment strategy
Plans and coordinates monitor training in conjunction with internal Study Delivery Teams
Develops monitoring plan, ensuring compliance and documents deviations
Facilitates the distribution of project instruction and monitoring tools to deployed Regional Monitors
Reports and updates monitoring project deliverables (site selection, site enrollment, site compliance) to Study Delivery Lead and ensures implementation of corrective actions at sites as needed
Identifies demand and manages deployment of flexible staffing resources to a given therapy/study team, maintaining adequate staffing to meet project needs.
Oversees and trains flexible workforce Monitors’ on delivery of project assignments including site management, audit follow-up, and general project support
Assists SDL/SDD in budget oversight related to monitoring
Ad hoc review of workforce monitor expense reports, site allocations
Ensures deployed regional monitors manage assigned sites understand and comply with the CSP, GCPs and SOPs
Maintains positive and cooperative relationship in day-to-day interactions and communications with internal and external customers
Ensures site monitoring visits schedule is adhered to and tracked, reviews site visit reports, site correspondence, telephone logs and other relevant documents to identify compliance issues and trends
Ensures patient safety is maintained and informed consent procedures are properly executed
Actively participates in pertinent project meetings, may present at Investigator Meetings, internal/external meetings and training sessions
Oversees study information input into Clinical Trial Management System (IMPACT), ensuring study information is updated
Proactively identifies study-related issues and provides timely resolution
Contributes to process development and improvement by sharing best practices
Provides monitoring expertise and technical information to SDTs
Ensures appropriate communication with all necessary stakeholders and partners to ensure communication and field alignment
Manages the deployment of workforce to given therapy teams
Assist Study Delivery Team in the interim and final database lock activities
Assist Study Delivery Team in the planning and oversight of adverse event database reconciliation
Assist Study Delivery Team in the planning and oversight of site closeout activities including issue resolution

REQUIREMENTS:

Demonstrates strategic influencing, analytical thinking, concern for standards, concern for impact, strong team skills including cooperation, willingness to learn from others, sharing of relevant information, adaptability, self-control, tenacity and conflict resolution skills
Has in-depth knowledge of the clinical study process, GCP/ICH guidelines and SOPs
Able to lead and facilitate regionally based flexible workforce, ensuring cross functional and in depth understanding of disease state/area and familiarity with latest research and industry best practices to the design and execute clinical studies
Demonstrates sound project planning and execution skills
Demonstrates advanced computer skills including troubleshooting
Excellent organization and time management skills; detail-oriented; ability to multi-task in a high volume environment
Demonstrates ability to prepare and present at internal and external meetings
Demonstrates Leadership, professionalism, diplomacy, mutual respect and embraces diversity
Demonstrates customer relationship building and management skills
Establishes professional relationships and networks with academia and national thought Leaders
Bachelor degree in biological science or health-care related field
Minimum of 4 years direct regional monitoring experience
SCRA or direct management experience, 6-8 years of relevant experience in industry with excellent performance
Advanced knowledge of the clinical study process, GCP/ICH guidelines
Practical knowledge of study management (i.e. IMPACT)
Experience in e-Clinical applications
Proficiency in MS Office Tools
Effective decision-making, ability to identify and understand issues, problems and opportunities
Excellent planning and organizational skills; ability to establish course of action for self and others to ensure deliverables are met
Ability to travel – Valid Driver’s License
Strong interpersonal and presentation skills
Excellent oral and written communication skills
Detail-oriented
Demonstrated effectiveness working independently, collaboratively with peers cross-functional teams, site personnel and field colleagues
Actively participates and contributes to team success

PREFERED BACKGROUND:

Demonstrated ability to successfully manage clinical studies to time and quality metrics
Demonstrated ability to lead a team
Internal and External Contacts/Customers
Clinical Investigators
Study Site Personnel
Study-specific advisory and/or steering committees
SD personnel
USDD personnel
External service providers
Universities, Academia and Thought Leads
Monitoring Vendor

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Bridgewater, NJ - Bio-Statistician with SAS Programming Skills

2011-09-20T16:31:00.001-07:00

JOB DESCRIPTION:

The position is to provide ongoing statistical support for multiple USMA oncology studies
The deliverables include reviewing statistical analysis plans (SAPs), performing data review, reviewing final and interim analyses and final study reports, in addition to providing general statistical oversight of these studies
The involved activities include attending clinical team meetings, interacting with study team members, working and providing statistical input to programmers, and providing periodic updates to management on the study timeline and activities

REQUIREMENTS:

Must have 3 or more years of industry experience
Experience in oncology area is preferred
Candidates should have a Ph.D. or Master degree in Statistics or related fields
The candidate must be able to communicate the requirements to the CSO and positively interact with the study team members in the Company to find solutions to the scientific and logistic problems
SAS programming skills are necessary
The candidate must be able to work 40 hours/week on site

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Wilmington, DE - ARIBA Systems Administrator

2011-09-16T17:37:00.000-07:00

JOB DESCRIPTION

Responsible for business analysis for enhancements and updates to the US and UK ezBuy systems

Qualifications:

Ability to draw out and understand business requirements and work with IS to implement
Stakeholder management skills
Ability to liaise between IS and the business clients
Requirements gathering, systems testing, functional design, change management skills required
Ariba Buyer expertise preferred but experience with other eProcurment systems (SAP SRM, Oracle iProcure, etc.) is acceptable
Will also be responsible for adding and maintaining e-catalogs in the ezBuy systems and enabling suppliers on the Ariba Supplier Network (supplier enablement)
Experience

REQUIREMENTS GATHERING
SYSTEM TESTING
FUNCTIONAL DESIGN
CHANGE MGMT SKILLS
ARIBA OR EPORCUREMENT SYS

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Newark, DE - Chemist

2011-09-16T17:32:00.001-07:00

JOB DESCRIPTION

To serve as Chemist / Senior Chemist in a QC laboratory in Newark
Will use HPLC and other lab equipment and systems to test tablets, finished product, raw material, and water

Qualifications:

BS in Chemistry or Biology
Good knowledge of wet chemistry and chromatography required
Able to competently use a range of laboratory computer and information systems
QC/Pharma experience or GMP lab experience preferred

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Malvern, PA - Scientific Process Operator

2011-09-16T17:28:00.000-07:00

JOB DESCRIPTION

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in the Formulations Manufacturing Cell
This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations

ESSENTIAL FUNCTIONS:

Executes manufacturing processes according to standard operating procedures
Verifies and enters production parameters per SOP and Batch Record on trained procedures
Retrieves and analyze trend charts and process data on trained procedures
Accurately completes documentation in SOP's, logbooks and other GMP documents
Demonstrate training progression through assigned curriculum
Accountable for adherence to compliance policies and regulations
Wear the appropriate PPE when working in manufacturing and other hazardous working environments
Takes necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors

ADDITIONAL RESPONSIBILITIES/DUTIES:

Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA and OSHA
Adheres to the Safety Code of Conduct & EHS policies and attend all required EHS training

Support the ongoing production schedule by:

Report to work on-time and according to the shift schedule
Be available for other duties as assigned
Attend departmental and other scheduled meetings
Good interpersonal and communication skills
Demonstrates positive team-oriented attitude in the daily execution of procedures
Promote and work within a team environment
Continue professional development through learning new skills, procedures, processes and seminars

*This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.

Qualifications:

Autonomy and Complexity

Basic Technical Knowledge within functional area
Introduced to troubleshooting of routine manufacturing processes
Needs direction to perform daily tasks
May offer suggestions for process improvements
Basic GMP understanding
Attend PE awareness classes and may participate PE projects

EDUCATION and/or EXPERIENCE:

0-2 Years Biotech/Pharmaceutical experience or equivalent industry experience
HS Diploma required

COMPUTER ABILITY:

Basic Understanding of MS Office, Windows and XP

LANGUAGE SKILLS:

Read and interpret documents such as safety rules, operating instructions and logbooks
Review and provide feedback for SOP and Batch Record revisions

REASONING ABILITY:

Interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Follows instructions
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Work with high level of concentration
Accept and adapt to procedural changes

MATHEMATICAL SKILLS:

Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals

OTHER SKILLS, ABILITIES OR QUALIFICATIONS:

Knowledge and ability to operate manufacturing equipment and hand tools

PHYSICAL DEMANDS:

While performing the duties of this job, the employee:
Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
Is frequently required to talk or hear.
While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms
Ability to lift 20 lbs

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Jacksonville, FL - Technical Writer - Scientific

2011-09-12T17:36:00.000-07:00

JOB DESCRIPTION

Basic Function:

Researches, writes and edits (pre)clinical reports, regulatory submissions, scientific publications, and/or technical business submissions
This position is also responsible for summarizing data from (pre)clinical studies
Develop cross-functional working relationships across internal Clinical, Regulatory and Pre-Clinical Development groups

Essential Duties:

Summarize preclinical reports and summaries
Write, edit regulatory compliance documents (i.e. Risk Management Reports in compliance with ISO 14971)
Management of document reviews
Support technical/clinical/regulatory writing for global regulatory submissions
Quality control of documents for content, uniformity, adherence to ICH/FDA/EMEA or other appropriate regulatory guidelines
Ensure compliance with company SOPs and style guidelines

Qualifications:

Outstanding written and verbal communications skills are mandatory
5+ years of technical/medical/regulatory writing and relevant device/ pharmaceutical industry experience
Related scientific and regulatory experience with knowledge of the technical medical writing process, required
Bachelor’s degree or higher in a related scientific discipline
Ability to work in a highly regulated environment with a strong attention to detail
Self-motivation and flexibility are required
Must be able to work effectively within a team setting (independently and collaboratively)
Ability to troubleshoot document formatting and template design issues
Expert on MS Office and commonly used PC applications
Knowledge of:

Understanding of current FDA regulations and guidelines, including but not limited to; ICH guidance documents, CTD, eCTD, IND, NDA, and CTA submissions
Understanding of medical terminology within the device and/or pharmaceutical industry
Knowledge of Risk Management principles a plus
Advanced knowledge of and experience with MS Word

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Raleigh, NC - Field Application Engineer

2011-09-12T17:31:00.000-07:00

JOB DESCRIPTION

The company is looking for a Field Application Engineer (FAE) based in Raleigh, NC
This individual will be responsible for supporting the company’s OEM customers designing the company’s silicon devices and systems into their products as well as VARs (Value Added Resellers) offering the company’s products as part of their solutions
Ideal candidate should have development background in the fields of board design, firmware development, low level device driver development or application software development
The candidate must show good overall understanding of system level issues and be familiar with hi-speed networking technologies and protocols (particularly 10/40Gigabit Ethernet, InfiniBand, Fibre Channel)
Responsibilities include technical management of accounts; participating in the project life cycle to include definition, design, software porting, reviews, bring-up and ongoing support; delegating issues to the company’s engineering and drive for solution; preparing and delivering technical training/presentations; and participating in pre-sales activities

Qualifications:

BSEE/BSCS or higher
3+ years HW/SW development experience or highly technical support experience
Knowledge of networking protocols, including layers 2, 3 and 4
Independent. Self-motivated. Dedicated.
Excellent communication skills
Up to 20% travel required
Knowledge in InfiniBand networking spec and protocol stack
Knowledge in storage protocols (block, file, FC)
Knowledge in C, C++ and scripting languages (BASH, Perl, Python)
Understanding of Linux/Windows/VMware/Solaris internals
Knowledge of IBM server products, design and qualification process
Prior or current experience working for IBM as an employee/consultant or supporting IBM as a customer
Understanding of server structure and its main components
CPU, memory, PCI subsystem, storage subsystem, network interface both from HW and SW perspectives

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Wilmington, DE - Clinical Procurement Manager

2011-09-12T17:24:00.000-07:00

JOB DESCRIPTION

A managing position providing leadership and direction within the team, leading
project level procurement/outsourcing activities across functions and globally as assigned
Leading the evaluation and selection of external vendors, using recognized criteria, including audits and feedback from previously conducted projects
The role require a high level of interactive communication as well as cultural sensitivity to set clear direction for the team and when managing external service providers
Lead and support the scope and commercial aspects of the external delivery solution (Procurement) for Drug Projects, managing a portfolio of external partners and providers
Lead regional cross-functional teams and participate in the evaluation and selection of external vendors aligned to the clinical strategy, using recognized criteria, including:

o audits feedback from previously conducted projects

o Cost benefit analysis on planned acquisitions

o Specifications, performance terms and / or acceptance criteria

o Contracts

Drive supplier performance through the application of appropriate supplier management measures and methods
Within area of accountability act as a point of escalation for the review and response to supplier inquiries, protests and appeals
Negotiate appropriate terms and conditions, that are in accordance with the contractual and commercial framework and based on the cpmpany’s MSAs, Project Agreements etc.
Guide project/delivery teams in managing risk and issue identification, escalation and resolution for global/local provider issues and through effective supplier management and business review meetings, where appropriate, to ensure ongoing assessments of overall ESP performance
This will involve liaising with the Business Relationship Managers
Ensure the Clinical Procurement Process is Compliant with all relevant regulatory and the company’s requirements e.g. Sarbanes Oxley, Code of Conduct, Financial Control Framework, GCP, Responsible Procurement, Supplier Sourcing Management Framework, etc.

Qualifications:

5 years+ of Procurement experience
Procurement experience in the Clinical arena
Experience developing complex contracts
Experience with pharma/clinical research organizations a plus
A college degree

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Wilmington, DE - CLINICAL EDUCATION & LEARNING PARTNER

2011-09-12T17:17:00.000-07:00

JOB DESCRIPTION

· Determine learning needs according to agreed strategy to achieve current and future business needs

· Design and project-manage medium-sized education programs that will drive improvements in the business performance

· Manage the portion of the central E&L budget as assigned to specific project(s) and ensure that it comes within agreed targets

· Work with internal and external Knowledge Experts to achieve desired programme content

· Develop contracts for each learning program and agree these with the CE&L Partner Lead to ensure that they are aligned with department and business objectives

· Develop evaluation data and metrics for defined education programs and use these to determine the impact of learning on department/business objectives

· Provide regular updates on projects and activities to the CE&L Leadership Team and key stakeholders

· Provide line managers with materials they can use to determine how learning is being transferred to the workplace

· Work closely with the CE&L Operations Section and provide the appropriate documentation and details for the CE&L Operations Section to develop quality materials and logistics to meet the program requirements

· Be part of the CE&L Partner network sharing best practice and learning

Help drive a learning and knowledge-sharing culture

Qualifications:

University degree or equivalent qualification
Experience in the Pharmaceutical industry, preferably within Clinical
Good working knowledge of the industry
Proven experience as an education professional with a wide knowledge of methodologies
Professional training qualification preferred (e.g. CIPD)
Specialist knowledge of design, development, delivery and evaluation of professional education programs in both classroom and electronic format
Proven track record in developing training materials to support clinical processes, procedures, skills and knowledge
Experience of using the Quantifying Performance Gap (QPG) process
Experience of managing a training budget
Proven project management experience
Proven strong facilitation skills
Needs analysis and post-training evaluation skills
Exemplary behaviours focused on the values defined by the company
Willingness/ability to travel both nationally and internationally

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New Brunswick, NJ - Contract Coordinator

2011-08-30T13:40:00.000-07:00

JOB DESCRIPTION

- Creates project work plans and work with manager to meet required timelines

- Manages day-to-day operational aspects of project

- Prepares for external management reviews

- Ensures project documents are complete, current, and stored appropriately

- Provides regular status updates to manager

- Resolves and/or escalates issues in a timely fashion

- Suggests areas for improvement along with possible solutions

- Collection and maintenance of questionnaires

- Data Entry

- Conduct worldcheck/D&B (if deemed necessary)

- Internet searches

- This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned by the Vice President of HCC&P

- Location: U.S. compliance operations hub (NJ); up to 10% travel may be required

REQUIREMENTS:

- Minimum of 5 years of experience in the pharmaceutical and/or medical device industries
- Proficiency in document management, both physically and electronically
- Knowledge of advanced search techniques such as Boolean operators, and ability to construct logical relationships among search terms
- Experience with development and preparation of information packages
- Process-oriented, with sharp focus and attention to detail

- Ability to juggle multiple priorities

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Wilmington, DE - IS Implementation Lead

2011-08-30T13:38:00.000-07:00

The Country IS Implementation Lead leads the IS delivery in the US for the HR outsourcing programme on-time, on-budget and in adherence with quality and compliance standards
The role has responsibility to manage/support the IS plans across the US as well as provide SME expertise in the RICE (reports, interfaces, data conversion and enhancements) elements for the entire technology lifecycle
The Country IS Implementation Lead shapes the country IS solution and acts as a liaison between the global IS, local IS, third party outsourced vendor and business stakeholders to ensure that the global business blueprint is effectively translated into the technical solution
The role will provide IS/IT SAP HR architectural expertise and technical direction to system development and integration projects
The Country IS Implementation Lead will partner with project managers, business analysts, and solution engineers to create solutions that are aligned to the architecture standards and principles, leverage common solutions and services, and meet the financial targets (cost and benefits)
Within the solution development lifecycle the role will be accountable for solution evaluation and selection, buy vs. build decisions, and early-phase project estimates which contribute to the business case
IS Project Management/Technology Implementation:
Provide technical support to project teams and conduct reviews throughout project lifecycle
Assist project and service teams in the development, implementation and maintenance of RICE (Reports, Interfaces, Data Conversion and Enhancements)
Act as a point of expertise on SAP HR for US and facilitate resolution of issues between HR in US and 3rd party supplier
Work with third party suppliers as required and contribute to the creation of local technical design documents
Document all architecture analysis and design work
Oversee execution of local technical project plans as defined in the IS Project Management Methodology (ISPMM) and AZ Project Management Framework (AZPMF)
Accountable for country related IS status reporting
Manage relationships with key business stakeholders and ensure that global technical blueprint is effectively captured and the impact of projects/ programmes is understood by the business
Manage delivery of local RICE (reports , interfaces , conversion and enhancement) activities
Manage IS resource plans and ensure effective sourcing and utilisation of resources
Drive resolution of risks and issues, involve other organizations/stakeholders as required
Develop transition plans into services, including controlled hand-over’s into support and maintenance
Ensure project/programme assurance activities are performed to confirm adherence to internal (ISPDM) and external (GxP, FTA, SOX) standards
Forecast and influence the provision of adequate resources in a timely fashion
Oversee IS delivery performance Provide subject matter expertise for HR and IS/IT related activities

REQUIREMENTS:

SAP HR experience on a large-scale programme (particularly experience with RICE elements (Reports, Interfaces, Data Conversion and Enhancements)
Global experience to work across delivering HR technology solutions across different geographies
Experience of developing and managing relationships with 3rd party suppliers
Ability to interpret and communicate technical information into business language and in alignment with the business
Proven track record in delivering high risk programme/projects and decision ma
Good business acumen
Demonstrate initiative, strong customer orientation, and cross-cultural working

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Wilmington, DE - IT Infrastructure Consultant

2011-08-26T17:26:00.000-07:00

JOB DESCRIPTION

Providing mainframe technical expertise and assistance to the Mainframe Elimination Team during the evaluation of supplier proposals for the elimination of the mainframe
Performing the role of the lead mainframe technical expert working on behalf of Company's throughout the mainframe elimination project
Providing mainframe technical expertise and assistance to the Mainframe Optimization (e.g. cost reduction) project which is working to reduce CPU consumption and resource units or costs associated with the mainframe

REQUIREMENTS

At least 10 years of experience supporting mainframe applications and/or system administration, prior experience with Company's mainframe environment, and a proven track record of technical expertise in the mainframe environment
The following IBM mainframe skills are required:

• The ability to analyze applications to determine if they are being used and by whom

• The ability to analyze and understand batch networks & interdependent batch jobs

• z/OS v1.9 systems programmer

• Job Control Language (JCL)

• Security tools including RACF

• Performance monitoring tools including CA-SYSVIEW

• Network protocols including SNA, Bisync

• Message oriented middleware including MQ Series

• Transaction Processing Monitors including CICS, IMS

• Batch scheduling including Control-M

• Programming languages including Cobol, Focus, PL/1, Telon

• Database products including DB2, IMS, Adabase, Supra

• Database interfaces including SequeLink

• Database/data gateways including DB2 Connect

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New Brunswick, NJ - Contract Coordinator/ Data Analyst

2011-08-26T17:22:00.001-07:00

JOB DESCRIPTION

Utilize COGNOS reporting software to identify and analyze data to support key organizational strategies
Create integrated analyses from varied data sources
Develop and maintain MS Excel and MS Access sourcing databases
Support Sourcing Managers with ad-hoc projects
Develop and maintain internal SharePoint data libraries and communication materials

REQUIREMENTS

Bachelor’s degree and 1+ years of experience in Analyst or similar role
Proficiency with database management tools and presentation of data analysis - COGNOS business software knowledge is a plus but not required
Strong quantitative and analytic abilities to analyze and validate data
Excellent computer skills (Excel, Word, PowerPoint, SharePoint, Access)
Exceptional interpersonal, communication and organizational skills
Detail oriented, dependable and motivated
Interested in learning new things and comfortable taking the initiative to seek out projects or new areas of responsibility

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New Brunswick, NJ - Contract Coordinator

2011-08-26T17:16:00.001-07:00

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JOB DESCRIPTION

The Business Analyst interfaces with third-party suppliers as well as internal stakeholders in order to assist the Company's Process and Technology team in managing the Supplier Diversity Program

Responsibilities

Tracks and reports spend with diverse suppliers
Identifies trends, risks and opportunities for increasing diverse spend
Collects and validates spend data from internal and external stakeholders
Performs and validates data uploads onto spend management system
Trains new system users and resolves potential system issues with IT team
Produces monthly Supplier Diversity dashboards and ad-hoc spend analyzes for Procurement leadership teams
Ensures accuracy of spend and supplier information in all data uploads, dashboards, and analyzes
Collects and documents information on projects affecting diverse spend
Proactively issues and implements recommendations for improving metrics, dashboards, systems and processes
Develops and maintains procedures, quick-reference guides, and internal SharePoint data libraries
Collaborates with Procurement teams to assess Savings and Supplier-Enabled Innovation delivered by diverse suppliers
Assists in various projects within the Process and Technology team

REQUIREMENT:

A minimum of a Bachelor’s Degree is required
Advanced proficiency in MS PowerPoint and Excel is required
Excel experience must include IF, AND, COUNT, and LOOKUP functions, pivot tables, charts and graphs
A minimum of 2 years of experience in business analytics, operations, strategic sourcing, or finance is preferred
Strong analytical thinking and problem solving skills are a must
Experience with MS Outlook and Word. Knowledge of MS Access and SharePoint is preferred
Detail oriented, dependable, and motivated
Exceptional interpersonal, communication and organizational skills
Ability influence internal and external stakeholders at various levels
Ability to manage multiple priorities successfully, meet deadlines, and work both independently or in cross-functional teams
Interested in learning new things and comfortable taking the initiative to seek out projects or new areas of responsibility

Skillman, NJ - Project Coordinator

2011-08-26T17:07:00.001-07:00

JOB DESCRIPTION

Company's compliance to new quality policies in the area of raw material chemical specifications to ensure consumer safety
Conduct internal and external supplier research (i.e., surveys, phone interviews, web research)

Collaborate with internal experts to quality-check information

REQUIREMENTS

Someone with 3 years of experience and they need to have been part of a project with good leadership skills
We need new candidates who have worked in a large environment, good communication skills, solid organizational and coordination skills
Someone who is smart and can think on their feet
They have to have worked in procurement or supply chain
Can display a history of Project Management and Leadership skills
Can accurately analyze and manage data, files, and e-mails
Accurately inputs data in databases/spreadsheet
Looking for recent grad with advanced technical/engineering degree (chemistry, engineering, management information sciences) with coops at Fortune 500 consumer products companies strongly preferred, or an individual with 3 years of work experience within Procurement or Supply Chain, again Fortune 500 experience preferred.”

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Skillman, NJ - Sr. Project Manager III

2011-08-25T16:20:00.001-07:00

JOB DESCRIPTION

Manages a high-level, complex project with IT components that involves setup of an off-shore Pharmacovigilance center
Responsibilities include management of the project within the constraints of scope, quality, time, and cost, to deliver specified requirements; resource allocation; business plan; design; and implementation planning
Regularly interacts with senior management
Coordinates and directs the activities of project team members
Responsible for cross-functional teams
Ensures all project requirements and/or objectives are documented
Manages one or more high-level, complex non-technical projects within the constraints of scope, quality, time, and cost, to deliver specified requirements
Projects may be strategic in nature
Responsibilities may include resource allocation and all phases of development life cycle (i.e. feasibility study, requirements, analysis, ROI, business plan, design, testing, and implementation planning)
Regularly interacts with management
Coordinates and directs the activities of project team members
May be responsible for cross-functional teams
Ensures all project requirements and/or objectives are documented
May obtain and manage external resources required for project completion

REQUIREMENTS:

10+ years of experience
Experience managing projects within the constraints of scope, quality, time, and cost, to deliver specified requirements; resource allocation; business plan; design; and implementation planning
Experienced managing one or more high-level, complex non-technical projects within the constraints of scope, quality, time, and cost, to deliver specified requirements

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Ann Arbor, MI - Marketing Specialist

2011-08-25T16:19:00.000-07:00

JOB DESCRIPTION

The purpose of the CRM/Sales Force Automation & Data Integrity Specialist job is to support attainment of W&P ENTERPRISE sales quota, revenue growth, contract/revenue retention through the timeliness, accuracy, and integrity of the CRM data and reporting, and management and optimization of SALES CRM/SFA processes and tools
The primary responsibilities for this job include: CRM data management, campaign and lead management, pipeline and other reporting, system optimization and configuration, provide user support
Loading and updating content / documents housed in Internal Documents and in Customer Content portal
Entering or loading lists procured from tradeshows, webinars, directories, etc.
Managing database ensuring bounced emails, duplicates, etc. are removed, new customer info added, changes in personnel ownership, etc.
Search on Jigsaw, internet, etc. to find and load desired contacts for specific marketing campaigns (i.e., Medicaid)
Manage Internal and Customer User IDs

Campaign & Lead Management

Attend planning meetings with Marketing for upcoming digital campaigns
Setting up campaign lists for all digital marketing campaigns (webinar invites, Engage, targeted campaigns, ENews, customer newsletter, tradeshow invitations, opt out to new leads, etc.
Assigning leads from web, phone, webinars, tradeshows, etc. to sales rep

Pipeline & Other Reporting

Pulling and distributing pipeline reports to management, field staff, requesting updates and reviews
Develop a process to ensure integrity and accuracy of all data in reports
Generate defined Sales and Marketing performance reports (e.g., vital factors, sales, dashboard, as defined and prioritized by Sales & Marketing business leaders
Creating standard and ad hoc reports as requested by Sales and Marketing leadership on pipeline, won/lost, marketing activities, field activities, etc.
Creating and maintaining dashboards for marketing and sales management

System Optimization & Configuration

Establish CRM/SFA user group and schedule and facilitate meetings to solicit user feedback, suggestions and requests
Work with end-users to explore ways to better use the CRM/SFA systems
Communicate user feedback and needs to CRM/SFA vendors and to W&P ENTERPRISE management
Work with user stakeholders to define additions and changes to existing configuration
Make system configuration changes and additions to support additional business requirements

Provide User Support

Deliver or coordinate the delivery of user training
Provide individual and group coaching on systems operations and capabilities as necessary
Respond to user questions and problems and ensure effective response/resolution
Take action to address CRM/SFA system problems and/or escalate issues as necessary and appropriate
Monitor, report user adoption and compliance

REQUIREMENTS:

Candidates must have Salesforce.com experience
Experienced supporting the process to manage and monitor sales quota, revenue growth, contract/revenue retention through the timeliness, accuracy, and integrity of the CRM data and reporting, and management and optimization of SALES CRM/SFA processes and tools
(SFA is Salesforce.com)
Bachelor’s Degree preferred
Three to five years of healthcare industry experience in similar position
Knowledge of sales/client services functions, business processes
Excellent verbal and written communication skills
Analytical/systems/innovative thinking
Customer focus
Ability to effectively handle multiple demands and competing priorities

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Raritan, NJ - Sourcing Manager

2011-08-24T16:08:00.001-07:00

JOB DESCRIPTION

Deliver Procurement-based competitive advantages across thecompany through the development and managing of sourcing analysts and by providing category analytics & metrics enabling the strategic value to the organization.

RESPONSIBILITIES:

Operationalize the sourcing analysts roles by developing partnerships with each of the Category Directors enabling global analytics across all category strategies.
Manage team of sourcing analyst(s) to include performance management, training, talent management, and adherence to all policies and procedures.
Provide leadership and framework to ensure consistent deliverables from sourcing analyst & sourcing manager to leadership
Support Supplier Relationship Management processes providing content, managing logistics and day to day escalations.
Lead compliance & metrics for all IT strategies across the company.
Develop and implement key performance metrics, tracking mechanisms, and non-conformance category reporting.
Develop corrective action plans to improve metrics and category strategy.
Lead departmental metrics and drive supplier rationalization strategies within the categories. Provide internal and external department reporting including spend, supplier diversity and operational metrics.
Partner with Category Directors to develop annual business plans, monitor supplier performance, and lead sourcing efforts to improve business results by maximizing use of leveraging opportunities.
Lead effective sourcing processes and systems for: external and internal requirements gathering, conduct financial and spend analysis, construction of a business case to maximize benefits utilizing PE methodologies.
Facilitate proactive contract expirations and renewals including the development of negotiation and agreement strategies.
Conduct benchmarking and competitive analysis to derive insights and market trends to enable category strategies – understand economics, industry, supplier risk profiles and supplier segmentation.
Provide backup to procurement analyst(s) including purchasing systems, data, and policies (e.g. Ariba, eICD, Ariba Sourcing, competitive bid policy, etc.).
Conduct root cause analysis and develop corrective action plans for mismatches, invoice-in-hand, use of non-preferred suppliers, and increase spend with diverse suppliers.

REQUIREMENTS:

BA/BS with 6 plus years of related experience in purchasing, procurement/sourcing, or planning. MBA/MS degree a plus
Demonstrated knowledge of global sourcing processes and systems
Adept at eprocurement tools, spreadsheets, database management including metrics and compliance reporting
Familiar with agreements, legal contract process and supplier negotiations
Strong leader and team player able to interact and lead at various levels within the organization
Ability to lead work teams and supervise analysts/associates
Excellent oral and written communication skills including the ability to communicate across all management and organizational levels
Knowledge of data analytics, supplier diversity, cost models and pricing structures to facilitate the review of vendor financial statements and the analysis of sourcing alternatives
Participation in supplier relationship management is a plus
Strong Leadership, partnering and influencing skills to align key stakeholders ; Understanding Johnson & Johnson procurement & sourcing processes & associated data elements; Strong Business Acumen
Well-developed Project Management, Presentation, and Facilitation skills; Decision Making/Problem Solving; Process Excellence to include defining and designing process flows; Demonstrated ability to deliver results ; Demonstrate ability to think strategically; Ability to lead and drive change across the organization

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Wilmington, DE - Senior Project Manager

2011-08-24T16:06:00.000-07:00

JOB DESCRIPTION:

The Wave Project Manager manages the program delivery for the North American wave of countries implementing the HR outsourcing program
The role has oversight of the program ensuring each element of the projects is on-time, on-budget and in adherence with quality and compliance standards
The role has responsibility to coordinate with a global team items such as UAT planning, knowledge transfer workshops, cutover process and key user identification and training
This wave of implementation includes all SET areas across Canada and US including R&D, Operations and Commercial segments of rhe client
The Wave Project Manager shapes the wave project plan and acts as a liaison between the global program team, local functions, third party outsourced vendor and business stakeholders to ensure that the global business blueprint is effectively translated into the an effective program
The Wave Project Manager will partner with the Waves team members including SMEs from finance, HR and IT to track key deliverables and milestones across country plans
The role is accountable to manage the project environment and ensure the third party is following established contractual project management methods including ISPDM methodology

RESPONSIBILITIES:

Support the CTL and lead country project teams to deliver improvements within the AZengage, Project Management Framework
At any point in time the job holder may be accountable for the delivery of a number of sub- projects which may be connected to form an integrated programme
Proactively propose project opportunities having identified opportunities for improvement and innovation in the project
Be accountable to the Country Transition Lead for the delivery of assigned project activities based on the agreed scope, deliverables, value proposition and benefits of the project through to adoption as business as usual
Build trust based relationships with key customers and suppliers
Secure cleint resources for relevant sub-projects ensuring that the plan is optimal and competitive in terms of time, quality and costs.
Provide expert advice on the use of project management tools and methods to the CTL
Drive the identification of potential areas of risk relating to the project and ensure implementation of contingency/mitigation activities, working with the NGA project manager to ensure risks are appropriately logged and managed
Drive the evolution of project plans and other key documents ensuring that project data are up to date and accurately reflect the agreed plan, in particular quality assuring the project plan developed by the NGA project manager

REQUIREMENTS:

College/university degree
Demonstrated skills in multi-disciplinary project management
Experience of effective working in a multi-cultural team
Planning experience with globally working teams, with virtual outsourcing arrangements including all phases of the project lifecycle including design, build, test and cutover
Proven experience working with 3rd party suppliers; strong negotiation skills
Proven ability to learn new information effectively
HR experience with Work Force Planning, Organizational Mapping and Payroll (ideally in PeopleSoft and SAP)
Extensive project management experience with a history of delivering significant activities
Solutioning experience; able to have a thorough understanding of a product and skillful in facilitating teams to solve related challenges
Demonstrated good team leadership
Knowledge of the Project Management Framework

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Skillman, NJ - Senior Project Manager III

2011-08-23T14:28:00.000-07:00

JOB DESCRIPTION

In this role, the individual would participate in business unit level strategy setting and decision-making forums, drive the successful launch of individual design projects within the franchise, and have responsibility for driving improvement in the overall GBU level Design Process Dashboard
While participating in GBU level strategy setting and decision-making forums, will establish credibility by providing leadership, perspective and innovative thinking in support of franchise goals
Will be the "go to" person for all franchise related design project opportunities
In the design project manager role, the individual leads projects from stage 0 to 5 of the new design development process
The overall goal is to maximize business impact while launching design programs on time
This individual must manage a matrixed team that includes representation from, Global Design Strategy Teams, Global Engineering, Research & Development, Marketing, Sales, Package Engineering, Operations, Purchasing, Regulatory, Finance, National Planning, Sales and Logistics
Individual provides frequent senior management updates on projects a highly matrixed, fast paced environment
As dashboard owner, project metrics would improve from overtime (launch cycle to launch cycle)
Utilizing Design Project Management dashboards, project metrics and lessons learned, this individual would drive improvement to increase the effectiveness, speed, and efficiency of Design Development Process for their franchise
Individual will apply their knowledge of Design Project Management and Stage Gate Methodology as well as Process Excellence Six Sigma, Lean, Design Excellence and/or Technology Transfer methodology in having projects sanctioned or leading projects to optimize the Design Process in support of their franchise

REQUIREMENTS:

Minimum Bachelor’s degree in Project Management, Engineering, Graphic Design, Industrial Design, or related field; MS/MBA/PhD preferred
Skills and competencies required include: Proven design project management skills, strong leadership skills, project planning, risk identification and elevation, strong influencing, strong communication and interpersonal skills, appropriate sense of urgency, problem solving skills, credibility with all levels of leadership
Ten years New Product Development experience preferred
Minimum five years project management experience required
Proven design project management success required
Understanding of global strategic business plans and ability to lead cross-functional teams in the translation of business strategies into winning design programs required
Interpersonal skills including leadership, independent thinking, ability to drive global programs required
Global communication being persuasive and effective, interdependent partnering skill a must along with influencing and negotiating skills required
Ability to travel globally 25% of the time required
Ability to master significant complexity required
Process Excellence/Six Sigma certification preferred
International work experience (multi-regional perspective; design and technical) preferred

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New Brunswick, NJ - Contract Coordinator

2011-08-23T08:39:00.000-07:00

JOB DESCRIPTION:

The Project Coordinator will be responsible for assisting with the Privacy 2011 Safe Harbor recertification efforts for the company.
In addition the Project Coordinator will support the Privacy Safe Harbor Process Excellence (Green Belt) team.

RESPONSIBILITIES:

Collaborate with US Privacy Operations to assist with the Safe Harbor Re-certification process for several Operating Companies.
Assist with the Green Belt Project Core Team
Assist with the assessments required for Privacy Safe Harbor Re-certification to government
Obtain and review existing inventory to ensure all systems/websites in scope are identified
Review contract templates for appropriate privacy language
Review training completion records to ensure training of all employees as required
Submit filing fees for Safe Harbor Certification with Department of Commerce
Update Privacy Website for new templates, work instructions as needed
Attend Green Belt Core Team Meetings and work with business partners on follow up items
Analyze data, consolidate information for Re-certification/Green Belt analysis
Update Privacy PowerPoint Management Presentation on a monthly basis
Assist to ensure that all appropriate/required documentation is stored on the Share Point/Shared drive.
Assist with upfront requirements to migrate to Pentana, a process and documentation storage system.
Schedule meetings with conference rooms as needed
Additional requests as needed

REQUIREMENTS:

Bachelor's degree required
Ability to Review Privacy regulations to obtain a basic understanding of U.S. federal and state data protection and privacy laws and Safe harbor Requirements
Ability to Review Process Excellence documentation to obtain a basic understanding of the Green Belt Process
Knowledge and experience in the application of web-based survey tools, website maintenance and/or knowledge of SharePoint is preferred
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) is required
Excellent English verbal and written communication skills
Project Coordination Skills
Ability to work in a complex business environment
Ability to work independently with limited supervision.
Detail-oriented, takes initiative, strong work ethic
Ability to prioritize assignments and shift priorities as needed.

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Wilmington, DE - Safety Specialist

2011-08-22T09:52:00.000-07:00

JOB DESCRIPTION:

The US Patient Safety Specialist serves as a Medical and Safety resource for synthesis, analysis, evaluation, and reporting of adverse event information in order to maintain an accurate safety products
The US Patient Safety Specialist serves as vital link in the timely classification, analysis and summarization of both investigational and post-marketed adverse event information
The US Patient Safety Specialist supports the multidisciplinary teams and other cross-functional teams within the company

ACCOUNTABILITIES / RESPONSIBILITIES:

Participates in the triage process for incoming documents to ensure timely and effective medical and scientific evaluation of adverse event information
Request follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes
Reviews adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA
Enter and maintain accurate tracking system for all AE reports (CRIMSON)
Have a broad understanding of Surveillance activities and the impact on individual case or group of cases can have on product labeling
Leads team in preparing, organizing, and reviewing tabulations for Regulatory reports
Assumes responsibility for completing special projects (i.e. IND Annual Reports, PSUR table preparation)
Supports Safety Surveillance, Safety Support - Compliance and Marketing Company and the US Clinical Teams
Serves as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues

REQUIREMENTS:

Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries and collection of safety data
Reflects the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
Working knowledge of technology required for Patient Safety
Excellent knowledge of FDA and ICH guidelines and reporting requirements
Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least two years of experience in Patient Safety
Bachelor s degree in science / healthcare related field or proven Patient Safety experience equivalence in a similar role, and an excellent clinical background. Advanced degree is preferred
Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting
Broad competence with medical, therapeutic and technical terminology
Able to work effectively as part of a cross functional team
Excellent verbal and written communication skills
Demonstrated capabilities in Project management, Time management, Presentation skills
Strong attention to detail and organization
Demonstrated ability to perform with minimal supervision
Works as a team player

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Skillman, NJ - Northstar Data Analyst

2011-08-22T08:08:00.000-07:00

JOB DESCRIPTION:

Map all Northstar datapoints including input, outputs, data owners and required frequency of review
Outline full Northstar data management process including what is updated, when, by whom, etc., and document full process in an SOP (This should include documented roles & responsibilities (RACI)
Execute data management process, determine initial data integrity level (define with key stakeholders if needed i.e. mfg locations are wrong, spec linked to wrong material, etc.)
Work directly with data owners to “cleanup” data and ensure robust data management process in place moving forward (This may include some level of training and education)
Provide periodic updates to sponsor/ leader on status of effort, including initial integrity level and results to-date
Time permitting, begin adding columns required for future requirements with Directed Pure Buy (BOMbay Project)
Provide input to a Northstar data governance model
Hold meetings with data owners and project sponsors as needed
Participate in Northstar related projects/ activities as necessary

REQUIREMENTS:

Experienced mapping datapoints including input, outputs, data owners and required frequency of review
Experienced outlining full data management process including what is updated, when, by whom, etc., and documenting full process in an SOP
Experienced executing data management process, determining initial data integrity level
Experienced working directly with data owners to “cleanup” data and ensuring robust data management process in place moving forward
Experienced providing periodic updates to sponsor/ leader on status of effort, including initial integrity level and results to-date

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Norristown, PA - SQL Server DBA

2011-08-17T10:59:00.000-07:00

JOB DESCRIPTION

The SQL Server database administrator (DBA) is responsible for ensuring the security, availability, integrity, and functionality of production databases
The DBA works with the development team to identify optimal physical implementation of the logical model
The DBA is also responsible for monitoring the production databases and providing support, including problem identification and remediation, as well as performance monitoring
The production DBA will ensure that all changes to production databases are fully tested and are secure against unauthorized access and accidental damage
The DBA will also assist is infrastructure work to standardize the SQL Server DB environment

The scope of responsibility for the position includes project support, as well as maintenance and support activities

REQUIREMENTS:

B.S. degree in computer science, management information systems, or equivalent work experience
Ability to work independently
Ability to manage multiple concurrent objectives, projects, or activities
Experience tuning individual SQL queries, database applications, and optimizing databases for performance
Experience supporting SQL Server databases 2000 and 2005
Experience in the Windows 2003 Server Operating System
5 years of relevant experience
Experience with logical data modeling, including developing and maintaining data model diagrams (ERD), facilitating structured data modeling meetings
Experience working in a highly available 24X7 database environment
Experience with installation, configuration and management of enterprise SQL Server databases in a clustered environment
Installation considerations
Installation validation
Installation configuration
Database mirroring
Log shipping
Upgrade to SQL Server 2005/2008
Patch management
Strong customer and business focus
Strong documentation and communications skills
Experience working with very large databases
Knowledge of page and extents
Files and filegroups
Transaction logs
Knowledge of database, table, index, partitions and view storage structure
Experience migrating database objects from development through test and into production
Experience monitoring events, log files and resource usage
Provide production DBA support for multiple customer facing applications
Work with development and support teams to identify and address performance problems
Ensure that databases are in compliance with company standards, as well as all relevant configuration determined by DBA team
Perform account management, in accordance with requests from Security group

Required Technical Skills:

Experience managing database operations
Services / Transaction log management
Backup and restoration
System database rebuilding
Import/Export of data
Copy/move data between servers

Preferred Technical Skills:

Experience with SSIS, SSRS
Experience working in a formal software system delivery methodology
Provide production DBA support for multiple customer facing applications
Support development of physical data model and scripts for application development
Design physical model for performance (denormalize; add indexes)
Work development and support teams to identify and address performance problems
Manage database backups and participate in recovery exercises
Perform necessary database upgrades and patches
Ensure that databases are in compliance with company standards, as well as all relevant configuration determined by DBA team
Perform account management, in accordance with requests from Security group

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Norristown, PA – Business Analyst

2011-08-16T11:03:00.001-07:00

JOB DESCRIPTION

· The (Sr.) Business Analyst is responsible for understanding the requirements of the business and assisting the business support team in a role encompassing both traditional BA tasks and occasionally more technical tasks

· In support of that responsibility, the (Sr.) Business Analyst will also assist subject matter experts, project managers, and business unit managers as necessary to ensure that related technical solutions meet the business needs, and are developed and implemented with high quality

· The scope of responsibility for the position includes general business support, project support, and application specific maintenance and support activities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Business Support

· Serve as a primary contact for Interchange Scheduling and Transmission Service activities and establish a positive, service-oriented relationship with supporting ITS departments to ensure timely and accurate delivery of IT services

· Learn the business – develop a deep understanding of the business functions and processes and communicate this understanding across the teams

· Document, track and resolve problems in business systems

Solution delivery

· Have primary responsibility for all functional deliverables other than application code (work estimates, requirements documentation, conceptual design documentation, detailed design documentation, test plans, migration plans)

· Schedule and participate in or facilitate and lead (Sr.) meetings as necessary (e.g., requirements definition sessions, design reviews, issue resolution, status meetings, etc.)

· Schedule and coordinate project and maintenance activities within the department or project team

· Assist project management team and department management in developing work plans, including scope, milestones, schedule, resources and deliverables

· Regularly develop status reports regarding workgroup or project team progress

· Determine and document functional requirements for projects in the client business area and for enhancements to client area systems

· Coordinate Change Management and Release Schedules

· Lead Production Migration / Production Readiness planning

· Ensure appropriate level of controls are applied to work efforts, including security requirements, to ensure efficient delivery of robust, effective business solutions

· Provide Quality Assurance review during the design, development and testing processes

· Participate in and lead system testing efforts

· Assist business clients in developing requirements for and integrating systems from external vendors

CHARACTERISTICS AND QUALIFICATIONS:

· To perform this job successfully, an individual must be able to perform each essential duty satisfactorily

· The requirements listed below are representative of the knowledge, skill, and/or ability required

· Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

REQUIREMENTS:

· B.S. degree in engineering, computer science, management information systems, or equivalent work experience

· 3-5 years of experience

· Strong customer and business focus

· Strong communications skills

· Experience using the Microsoft Office suite

· Experience with SQL

· Demonstrated ability to support multiple projects concurrently

· Demonstrated ability to produce high quality work products with attention to detail

· Experience working in a software system delivery methodology

· Experience working with business and technical staffs to define, document, and track software requirements and design

· Experience defining and documenting software requirements

· Experience documenting software designs

· Experience developing testing artifacts, such as test plans and test cases

· Experience testing software systems

· Experience using Microsoft Project

· Experience designing complex technical applications

· Excellent knowledge regarding Oracle and SQL

· Good knowledge of web technologies (HTML, PHP, XML)

· Development background ( PL/SQL, Java, batch scripting, XML, Java Script)

· Experience with, or understanding of PJM's System Operations application systems (e.g., eSuite, EMS, eDart, OASIS, PI, etc.)

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Norristown, PA - Database Administrator

2011-08-16T09:55:00.000-07:00

JOB DESCRIPTION

The database Administrator is responsible for managing development, testing, staging, training and producing database environment
The Data Admin is also responsible for creating processes and scripts that will improve proactive monitoring of database performance, availability and security
In the process admin will also be responsible for developing shell scripts, PL/SQL script
In addition, the Data Admin is responsible for monitoring the databases, identifying problems and providing quick, efficient remediation, as well as performance monitoring
The data admin will follow all standards, policies, procedures and security requirements of the IT department and the DBA team
The scope of responsibility for the position includes project support, as well as maintenance and support activities
Data and Integration Services Department Summary:
Data and Integration Services department is responsible for managing data from end to end
The department is responsible to make sure data available all the tim
In addition to testing each individual product/application, this team is also responsible for testing the interactions of these products among themselvesSuch interaction mechanisms include but are not limited to SOA enabled Enterprise Service Bus, database transfers, replications, triggers, flat files etc.

JOB RESPONSIBILITIES:

Monitor different environment databases
Develop new processes and scripts to enhance monitoring of GoldenGate and Oracle processes
Work with the application development and support teams to identify and address performance problems
Perform necessary database upgrades and patches
Ensure that databases are in compliance with company standards, as well as all relevant configuration determined by DBA team
Perform account management, in accordance with requests from Security group

REQUIREMENTS:

DBA must have good working real time experience in ASM, RAC, DG and Golden Gate technology
Admin experience in Oracle 11g installations, ASM configuration, creating multiple node RAC database is desirable
B.S. degree in computer science, management information systems, or equivalent work experience
2 years working experience of GoldenGate
2 years working experience in RAC, ASM and DataGuard
Experience tuning individual SQL queries, database applications, and optimizing databases for performance
Experience with data extraction, data export and import tools
Experience supporting ORACLE 10 G in an AIX/UNIX environment, Data Pump
Real time working experience on Data Guard, RAC, ASM technologies
Experience with logical data modeling, including developing and maintaining data model diagrams (ERD), facilitating structured data modeling meetings
Experience working in a highly available 24X7 database environment
Strong customer and business focus
Strong documentation and communications skills
Experience with PL/SQl
Experience working with very large databases
Experience migrating database objects from development through test and into production environments
ORACLE certification
Experience working in a formal software system delivery methodology

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RARITAN, NJ - Microbiologist I

2011-08-16T09:42:00.000-07:00

The world’s premier consumer health company. The world’s largest and most diverse medical devices and diagnostics company. The world’s third-largest biologics company. And the world’s sixth-largest pharmaceuticals company.

REQUIREMENTS:

Bachelor's Degree
Proficient in microbiological testing according to USP and AAMI
Familiar with disinfectant efficacy studies and be able to perform this testing with some guidance
Capable of performing lab investigations and be an active participant in the problem solving
Must have industrial microbiology experience, minimum of 2 years preferably
Capable of developing, writing and revising standard operating procedures in addition to generate study protocols and complete reports
Knowledge in operating a sterility test isolators and AAMI natural product resistance testing (NPRT) would be a plus

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New London, CT - CPW Medical Writer

2011-01-24T15:58:00.000-08:00

Job Description:

Supports medical writing activities for Clinical Study Report (CSR) production following specified processes, guidelines, and templates utilized by the company - conforming to ICH-E3 guidelines and the company’s Global Document Style Guide
Liaises with CPW Medical Writing Point of Contact (PoC) for adhering to timelines and ensuring all requirements of the CSR are met
Participates in regular study team meetings when CSR topics are discussed
Coordinates review meetings as required with clinical study team to review CSR and collect comments for incorporation into the CSR
Ensures CSRs accurately reflect the data presented in the statistical tables and listings and other information sources
Develops and maintains knowledge of all applicable global regulations and guidelines, SOPs and practices

REQUIREMENTS:

4-7 years of experience working on Oncology writing
Experienced supports medical writing activities for Clinical Study Report (CSR) production following specified processes, guidelines, and templates
Experienced liaising Medical Writing Point of Contact (PoC) for adhering to timelines and ensuring all requirements of the CSR are met
Experienced participating in regular study team meetings when CSR topics are discussed
Experienced coordinating review meetings as required with clinical study team to review CSR and collect comments for incorporation into the CSR
Experienced ensuring CSRs accurately reflect the data presented in the statistical tables and listings and other information sources
Experienced developing and maintaining knowledge of all applicable global regulations and guidelines, SOPs and practices

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Wilmington, DE - Forecasting Manager

2011-01-24T15:51:00.000-08:00

Job Description:

This position will be based on-site in Wilmington, with occasional trips to Gaithersburg to work with the Asthma team
Lead the development of long term forecasts for projects approaching Investment Decisions, in particular the development of a Diabetes market forecast to include both Onglyza and Dapagliflozin, and an Asthma market forecast

REQUIREMENTS:

BA/BS in Business, Accounting or related fields
Experienced forecasting investments and market analysis
Experienced with forecasting tools including MS Excel
Excellent verbal and written communications skills

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Raritan, NJ - Communication Specialist III

2011-01-24T15:45:00.000-08:00

Job Description:
The Technology, Shared Services organization is currently recruiting for a full time Communication Specialist to provide communications support for large, internal, global communication programs in Global I/T Quality & Compliance, and to an extent also in Global I/T Operations. The Communication Specialist will report to the Manager, Global I/T Operations and Q&C Communications.

Roles & Responsibilities:
The Communications Specialist will partner with the Global I/T Quality & Compliance organization to:

Promote the Global I/T Quality & Compliance value proposition, processes, contact points and strategic and partner projects
Provide communication strategy, planning, and support for large scale Global I/T Quality & Compliance programs and projects to key stakeholders including all Johnson & Johnson employees
Develop and write all communication deliverables for large scale Global I/T Quality & Compliance programs and projects including email announcements, Intranet Portal articles, FAQs, etc.
Manage the day to day activities for the Global I/T Quality & Compliance section of the I/T Intranet Portal using Microsoft SharePoint technology
Assist Global Communication Manager with meetings and events, including presentation development, event management and executive support
Assist Global Communication Manager with executive communication support
The Communications Specialist will also assist the Global Communication Manager and her team with meetings, events, and communication deliverables for the Global I/T Operations organization

REQUIREMENTS:

Minimum of a BA/BS degree in Communications or a related field is required
Minimum of 5 years of experience in Communications is required
Experience in information technology is not required, but valued
Experience with internal communications is required
Cross-functional team experience is preferred
Strong technical proficiency in Microsoft Office (Outlook, Word, PowerPoint) and Microsoft SharePoint is preferred

The Communications Specialist should have the following strengths:

A flair for creative writing and turning technical content into compelling story lines
Strategic and big picture thinking with an eye for detail
An ability to translate strategic messages to a variety of audiences, including senior executives, leadership, I/T partners, and internal employees
Good networking skills

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New London, CT - Development Operations Financial Analyst

2011-01-20T19:38:00.000-08:00

Job Description:

This role will provide support for Development Operations
The analyst will provide support for various financial activities including financial reporting, budgeting, forecasting, month-end close and presentation development for various functions within Development Operations
Ad hoc project support and analysis is also anticipated
Reporting – Regular monthly and ad hoc reports to include actual results, comparison to established target levels, and forecasted estimates
Will include identification of variances, an understanding of operational drivers, and defining implications to the business along with suggested actions
Budget Development – Help prepare and submit the annual budget, including funding levels, capital planning and the categorization and timing of spend
Forecasting – Responsible for ongoing analysis of spend and the identification of variances and changes in requirements
Month End - Processes monthly transactions to the general ledger along with other required activities
Business Analysis Support - Develop a broad understanding of Development Operations financial and operational issues, to provide critical business analysis support to Development Operations, including return on investment resource optimization, productivity analysis, cost savings identification, implementation support and tracking, etc

REQUIREMENTS:

Analytical skills Required 4-7 Years
Budget Forecasting Required 4-7 Years
Budget tracking Required 4-7 Years
The ideal candidate will have superior financial and analytical skills and a proven track record of professional, academic, and personal achievement. The ability to provide accurate financial planning, forecasting and reporting through rigorous analyses is key to success in this position
Knowledge of key strategic and operational drivers in the pharmaceutical industry would be beneficial
MOST CRITICAL SKILLS: Financial and analytical skills. Budgeting, forecasting, scenario planning, economic modeling
REQUIRED PERSONALITY TRAITS: independent, good communication skills, responsible, professional
Bachelor’s Degree required. MBA and/or CPA strongly preferred, with at least 5 years of related business/financial experience
Superior Excel Skills – Vlookups and Pivot Tables
Accounting – Knowledge of basic accounting principles i.e. GAAP
Knowledge of Financial Planning and Reporting Tools - Cognos, Business Objects and Computron
Presentation Development and Delivery – PowerPoint with Business Objects and Excel data

Core Competencies:

Decision Making - Decisions have moderate effect on the delivery of scheduled work and may affect allocation of existing resources.
Teamwork - Applies technical skills and discipline knowledge to contribute to achievement of work group/team goals.
Autonomy - Works under general supervision. Performs assignments using established procedures and general instruction.
Communication - Able to communicate in a variety of media. Lack of clarity and brevity is rare and usually associated with more complex issues

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Wilmington, DE - Clinical Education & Learning Partner

2011-01-20T19:32:00.000-08:00

Job Description:

Role is Clinical Education & Learning Partner within the Quality & Capability Development function
The contractor may be assigned to one or both of the following projects: Education & Learning support for Payer into R&D; Capability Development for skill groups within Clinical Development

Specific skills required are:

Project Leadership/Management; Stakeholder Management; Vendor Management; Knowledge of E&L Processes
Determine learning needs according to agreed strategy to achieve current and future business goals
Design and project manage medium to large education programs that drive improvements in business performance
Work with internal and external knowledge experts to achieve desired program content
Develop and agree contracts for learning programs
Develop metrics for defined learning programs and use these to measure the impact on business goals
Work closely with E&L Operations to ensure learning materials meet agreed business goals
Be part of the CE&L Partner Network and share best practice and learning

REQUIREMENTS:

Degree / College Major: Life Science Degree preferred University degree or equivalent qualification
5-10 Years Work Experience Required
Experience in the Pharmaceutical Industry, preferably within Clinical. Good working knowledge of the industry
Proven experience as an education professional with a wide knowledge of adult learning methodologies
Professional training qualification (e.g., CIPD)
Specialist knowledge of design, development, delivery and evaluation of professional education programs in both classroom and electronic format
Proven project management experience
Proven facilitation and influencing skills
Learning needs analysis and post-training evaluation skills
Willingness to travel nationally and internationally

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Groton, CT - Formulation Scientist

2011-01-20T19:26:00.000-08:00

Job Description:

Position in the Research Formulation group as a laboratory scientist
Role entails the development of pre-clinical and early clinical formulations, using various solubility/dissolution enhancing technologies for oral and parental administration to animals and humans
Candidate will measure and/or calculate physical properties of organic compounds, such as, solubility, dissolution rate, particle size, crystallinity, melting point, chemical stability, and partition coefficient in a self-sufficient manner
Candidate will also develop and conduct assays, using liquid chromatography, UV spectroscopy, calorimetry, and microscopy
Additional responsibilities include thorough scientific documentation (e.g., notebook records and technical summaries), data analysis and interpretation as well as presenting and/or publishing significant findings

REQUIREMENTS:

1-3 years of experience with Formulations
BS in Pharmaceutics, Pharmacy, Biology, Chemistry, or Chemical Engineering

Desirable Requirements:

MS in Pharmaceutics, Pharmacy, Biology, Chemistry, or Chemical Engineering
0-5 years laboratory experience
Independent research during college, summer employment, or prior work experience in a chemistry or pharmaceutical science laboratory
Ability to succeed in a team environment
2+ years Academic or industrial experience in HPLC analysis or experience in oral dosage form development
Good written and oral communication skills. Capability in oral solution and oral suspension dosage form development
General understanding of PK/PD relationships

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Groton, CT - Synthetic / Organic Chemist

2011-01-20T19:12:00.000-08:00

Job Description:

Multi-step synthesis, purification and structural characterization of compounds using traditional or parallel methods
Contemporary awareness and knowledge of organic synthesis in order to independently troubleshoot reactions through mechanistic understanding, as well as to contribute to the design of synthetic routes
Maintain a safe and productive work environment
Participate in chemistry and project team meetings

REQUIREMENTS:

Synthetic Methodology/Reagents Required 1-3 Years
Master’s Degree (preferred) or Bachelor’s Degree with experience in synthetic organic chemistry or medicinal chemistry
MUST HAVE 3-5 YEARS RELATED EXPERIENCE ALONG WITH THE ABOVE EDUCATION REQUIREMENTS
Experience in conducting multi-step synthesis, the ability to use chromatographic techniques to isolate and purify compounds and expertise in characterizing novel compounds using analytical techniques such as NMR, MS and IR
Excellent communication skills, a willingness to work within a team-oriented environment, and aptitude for learning new technology related to automated synthesis and purification, route design and data analysis are desirable

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Titusville, NJ - SAS Programmer III

2011-01-20T19:00:00.000-08:00

Job Description:

To provide SAS programming support for the Programming functional area.
Main Focus: receive general instructions; Complete assignments accurately and in a timely fashion with no supervision; anticipate & investigate unexpected difficulties with program/data
Develop and document programs to create/verify analysis datasets summarizing key clinical trial data
Develop and document programs to produce/verify tables, listings and other reports and analyses summarizing clinical trial results
Perform quality control checks for programs and data
Review the protocol, case report forms, and Data Management documents
Review and discuss Statistical Analysis Plan (SAP) and statistical programming specifications
Create analysis databases and generate analyses and reporting outputs
Demonstrate a good understanding of FDA, ICH and CDISC guidelines
Interact with CROs and review their deliverables as needed
Review programming deliverables from team members if needed
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned

REQUIREMENTS:

Bachelor’s degree or equivalent in computer science, mathematics or other scientific field (or equivalent theoretical/technical depth)
Minimum of 5 years of experience programming and analyzing scientific data in a pharmaceutical / clinical trial environment
Expertise in SAS programming language
Experience working in a PC SAS environment
Must have good organization and written and oral communication skills

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Durham, NC - Designer Drafter

2011-01-18T18:26:00.000-08:00

REQUIREMENTS:

Work from rough drawings, sketches or notes provided by Engineering personnel
Prepare sketches or complete detail and layout drawings from verbal or written instructions for complex products or equipment
Design & development of component part drawings to support general machine design of equipment
4-7 years of experience using Solidworks - desired
Thorough knowledge of equipment assembly procedures as it applies to the development of assembly drawings
Understanding of the construction and use of indented bills of material and their relationship to upper level assembly drawings. Input B.O.M.
Design and develop new models, mechanisms, or adaptations for a particular product or application
General understanding of equipment system controls
Operate 3D model and 2D CAD drafting software as part of design process
Must be able to design machine components from concepts laid out by more senior people
Knowledge of materials, and strength/sizing calculations is required
AS or BS degree in mechanical engineering is desirable, but not required with demonstrated design capability

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New London, CT - PA&B SharePoint Developer/Administrator

2011-01-18T18:21:00.000-08:00

Job Description:

Analyzes specifications, designs logic, writes code, customizes products, tests, debugs and documents software applications
Coordinates with other technical teams to ensure compatibility with other modules and applications
Consults with users and stakeholders to ensure that requirements are met
Enforces change management policies
Stays abreast and trained in advances in their specific fields
Familiar with software development lifecycle and configuration management
Developer/Analyst - works directly with technology managers, business users, and vendors/partners in developing and managing projects from inception to deployment, including support and maintenance

REQUIREMENTS:

.NET Desired 1-3 Years
MS Visual Studio Desired 1-3 Years
MOST CRITICAL: MUST HAVE AT LEAST 4 SOLID YEARS SHAREPOINT EXPERIENCE
SharePoint Administration Required 4-7 Years
WILL BE PERFORMING SHAREPOINT SITE COLLECTION ADMINISTRATION 25% OF THE TIME AND HELPING WITH DEVELOPMENT 75% OF THE TIME; SUPPORTING 2,000 USERS; CANDIDATE WITH SHAREPOINT CERTIFICATION HIGHLY DESIRED
Provides expertise in software development, systems analysis and some project management
Experience with Performance Analytics & Benchmarking
Understands and implements the business needs of the business and successfully design and develop software solutions to satisfy business requirements

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Wilmington, DE - Project Management Associate

2011-01-18T18:16:00.000-08:00

Job Description:

Provide support to the program and portfolio management groups by administering the project plans in Opal
Ensuring quality of information in plans, and reporting on project status
Escalating issues with forecasting and budget variances
Working closely with program management group to maintain quality in plans and working with portfolio management group to report on status of project forecast and budgets
Support of data in Planisware Tool
To support Program Management team with Plan Generation and maintenance activities in the Opal operating model at Plan Initiation, major revision and closure including; advice and assistance on the most appropriate use of Project level activities based upon Activity Libraries
Working proactively to support the Global Program Management team.
To provide ”hands-on” support in the Planisware toolset as needed on an issue driven basis
To provide input to portfolio reporting during portfolio analysis, performance measurement, scenario planning, or preparation for business reviews
To provide expertise in best OPAL practice and advise the Global Program Managers on appropriate best practice for scheduling, resource, and revenue forecasting
Accountable for monitoring compliance and quality, and aiding the Program Managers to continually improve the quality of the GDD IS OPAL data (project activities are linked appropriately, plans are consistent with activity library terminology, and project plans are routinely updated).
Creating ad hoc or standard reports for reporting on project/portfolio performance
Manages change with a positive approach to the challenges of change for the team and the project
Sees change as an opportunity to improve performance and add value to the business

REQUIREMENTS:

Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills
Good problem solving skills
Demonstrated ability to manage priorities, resources, and project initiatives in a global and regional environment
The manager is looking for a candidate with strong communication skills and very strong project management skills
Knowledge of the Planisware tool, OPX2, is a huge plus
Knowledge of the principles, concepts, and application of Project Management
Good working knowledge of the financial processes and management used in the delivery of an IS project

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Wilmington, DE - Sr. SAS Programmer

2011-01-18T18:10:00.000-08:00

Job Description:

The contract programmer will produce tables, listings, figures for the Clinical projects and support the qc effort of the same
They will also provide review and input into submission-level work (such as data definition files)

REQUIREMENTS:

5+ years with SAS and Clinical
Experienced producing tables, listings, figures for the Clinical projects and supporting the quality control effort of the same
Experienced reviewing and inputting into submission-level work (such as data definition files)

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Wilmington, DE - Paralegal

2011-01-18T18:04:00.000-08:00

REQUIREMENTS:

Bachelor Degree required
Paralegal Certification
Person well-versed in contractual legal language, specifically negotiating various documents such as confidentiality agreements, clinical study agreements, and investigator-sponsored study agreements with emphasis on sections pertaining to Intellectual Property, Indemnification, Confidentiality
Able to negotiate language and budgets with Clinical Trial Sites
Experience in amending clinical site contracts and preparing termination letters
Some experience in negotiating master clinical study agreements and confidentiality agreements
Expertise in preparing site budgets through a Fair Market Pricing tool is a plus, but not necessary
Person will work in a team environment with 7 other staff members

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New York, NY - Data Reconciliation and Research Clerk

2011-01-18T10:20:00.000-08:00

Job Description:

Candidate will be responsible for assisting the company’s Data Strategy & Reconciliation team in the data clarification process across data sources by accurately associating payments to a unique profile ID in our database of health care practitioners (HCP) profiles, by using a look up utility
Candidate must also be able to conduct internet research and other searches to ensure that we can accurately identify an HCP
Candidate may also be asked to do special projects involving Excel spreadsheets, or sending out e-mails

REQUIREMENTS:

Candidate must be detail-oriented, have the ability to focus despite highly repetitive tasks, be prompt, self-motivated, a hard worker, and truly understand the importance of the work (that it will be published externally)
High proficiency in Excel & Outlook, proficiency at conducting internet searches, and great communication skills are a must
Experience with Quality Management is desired

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Skillman, NJ - Global Recruiter

2011-01-18T09:55:00.000-08:00

Job Description:

Contract Recruiting Consultants to manage the recruiting process for assigned positions as a member of the Global Recruiting Team
In this role you will be onsite to support recruitment efforts in areas such as Pharmaceutical Research & Development, Commercial Pharmaceutical, and Supply Chain
You will partner closely with Human Resources to manage the recruiting process from end-to-end, and collaborate in creating staffing plans, developing strategies and implementing action plans
This includes but is not limited to: Developing job appropriate behavioral and competency based interview questions; Coach hiring managers or teams on interviewing and candidate assessment techniques; Identify and share recruitment best practices across business units of focus; Maintain current knowledge in business, marketplace, legal and recruitment trends and requirements; Initiate and maintain a network of contacts to help identify qualified candidates for hiring needs
In addition you'll be responsible for interviewing prospective employees and evaluating candidates for employment factors such as job experience, education and training, knowledge, skills and abilities, organizational culture considerations, and other data pertinent in classification and selection for a wide variety of non-exempt and exempt positions in multiple functional disciplines
Gather candidate feedback from interview team and lead final assessment and selection process, prepare a rating on applicants, negotiate offers, and consult on recommended starting salaries and other offer package details including, but not limited to, sign on bonuses, relocation, vacation, stock options, annual bonus, etc.
Facilitate the relocation of transferred employees, check professional references and perform other candidate due diligence activities in compliance with the recruitment operating procedures
Ensure exceptions are properly authorized by next level management
Gather/compile/maintain/provide regular metrics for HR-related activities
Manage the data associated with the recruitment process to ensure all relevant data on applicants, the process and the final hiring decision is properly handled in a timely manner
Provide company information to candidates and appropriately 'sell' candidates on the value proposition of the company’s experience

REQUIREMENTS:

A minimum of a Bachelor's degree is required
A minimum of 10+ years of experience in a high volume recruitment position is required
Previous experience working in a corporate recruiting capacity is preferred
A demonstrated capability in recruiting for wide variety of non-exempt and exempt positions within Pharmaceutical Research & Development, Commercial Pharmaceutical, and Supply Chain is desired
Excellent interpersonal communication, customer-service and organization skills required
Must have a demonstrated ability to apply judgment to ambiguous or out-of-policy situations
Attention to detail and the ability to deal appropriately with confidential information required
Ability to handle multiple projects simultaneously is required, as is the ability to develop relationships and influence others
Must have demonstrated knowledge and experience in HR recruiting processes and practices (i.e., compensation, EEO laws, interviewing skills, sourcing strategies, etc.)
Ability to work within a team approach is required
Experience with applicant tracking systems required, preferably Taleo (Recruitsoft)
Must have strong account management, consulting and interviewing skills
Strong customer and marketplace focus; negotiation and influencing skills; project management, and time management are required
DDI/Targeted Selection or other Behavioral Based Interviewing Certification is highly desirable
Knowledge of the applicable business marketplace is highly desirable

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New Brunswick, NJ - Statistician - Level III

2011-01-18T09:44:00.000-08:00

Job Description:

The Evidence Based Medicine (EBM) group consults with all of the MD&D Franchises to help demonstrate Value Proposition (Effectiveness and Affordability) for our products and services
Healthcare Informatics team within the EBM group undertakes observational research to support development, launch and post-marketing assessment of MD&D products
The team provides analytical services using large administrative, patient-level databases to answer a variety of question involving Clinical R&D, Safety, HEOR, Commercial Assessment and Marketing activities
The principal goal of this position is to support EBM research analyzing patient-level database(s) to evaluate disease natural history, standard of care, cost/reimbursement patterns, market size, site of care, co-morbidities, clinical, safety and health economic outcomes for R&D decision support and assessment of new innovative technologies
This position will work closely with colleagues within EBM team to formulate and address research questions using a variety of analytical and data-mining techniques
The person will provide rapid analysis to help inform product related decisions at Franchise and GOC level
The position will also help disseminate analytical information through white papers, publication in peer-reviewed literature, and reports for submission to regulatory and/or payor bodies

REQUIREMENTS:

PhD degree in Public Health, Health Economics, Biostatistics, Epidemiology or a related field required
Experience in Cost/Utilization analysis a plus
Minimum 5 years of experience working with large administrative, patient-level databases is required
Strong expertise in SAS is needed
An understanding of observational and experimental study designs, as well as and quantitative methods is required
Strong written and verbal communication skills, a strong publication/presentation record as well as ability to work independently is desirable
Pharmaceutical/Medical Device industry experience preferred

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New London, CT - Contract Recruiter

2011-01-18T09:27:00.000-08:00

Job Description:

The company has an opportunity for a Contract Recruiter to join their team in Groton/New London supporting the Worldwide Research & Development Division
The primary function of this position will be to help manage our growing Post-Doctoral Recruitment Program
As a Recruiter for the company you will be responsible for the full lifecycle recruiting process for the positions approved for the program, which are expected to be located at our various R&D Sites across the U.S.
You will partner with the designated Recruiting Manager to implement effective recruitment strategies as well as participate in the selection process including assessing candidate applications, screening, interviewing and recommending finalists
You will be expected to ensure compliance with federal and state regulatory requirements along with company policies

Responsibilities will include:

Learn sourcing techniques from recruiter team in order to build a candidate pipeline for selected positions
Manage client expectations – provide guidance to line management and set mutually agreed upon expectations regarding the full life cycle recruiting process
Builds and maintain a competitive intelligence database qualifying and extracting information from multiple sources to create a candidate pipeline for current and future hiring needs
Strive to increase diverse representation in candidate pools and interview slates
Conduct phone screen interviews for any site positions as requested by recruiters
Utilize interview techniques that identify high-potential candidates by applying specific behavioral and situational competency-based, appropriate fit questions for the department
Reaffirm the company’s values, culture, and opportunities when communicating the offer package to candidates (including compensation, health & welfare benefits, and relocation benefits)
Enter data into system, ensuring the integrity and timeliness of data entered
Support site stakeholders on ad hoc recruiting reports that are requested and partner with site Recruiting Manager and Service Center on delivery of core reports

REQUIREMENTS:

College Degree or Equivalent Related Work Experience
Experience recruiting in pharmaceutical or biotech industry is preferred
Proficiency with Microsoft Office and other business support applications
Minimum of 3 years of corporate recruiting experience or demonstrated equivalent performance level
Proficiency with recruiting tracking technology, preferably PeopleSoft Recruit
Demonstrated understanding of the various steps in the recruitment process
Highly flexible and motivated
Ability to work independently as well as in a team setting
Strong problem solving skills and ability to manage recruiting projects
Must be able to multi-task, work well under pressure, tight deadlines, and handle multiple priorities simultaneously
Proven organizational, interpersonal and communication skills (both written and verbal), as well as sensitivity for handling confidential information
Ability to build and manage strong business relationships

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Skillman, NJ - Scientist I

2011-01-17T11:18:00.000-08:00

Job Description:

We are currently recruiting for a Scientist to support Technical Transfer in Skillman, NJ
The Scientist will support a broad range of consumer products such as Skin Care, Beauty Care, Baby Care, Oral Care, Wound Care and Women's Health Care from a manufacturability and formulation standpoint
The scope of work includes supporting senior scientists within the group to conduct lab DOE, specification and documentation development, execution of none complex projects
The individual will work under supervision and drive to meet project timeline

REQUIREMENTS:

It is required that the candidate have at least B.S. degree in Chemical Engineering or related scientific discipline
In addition the position requires a 0-5 years of consumer industry experience
MS Office (Word and Excel) proficiency, excellent oral and written communication skills are required
Experience with consumer products, such as skin care, skin cleansers, hair care, oral care, baby care and/or deodorant products is desired

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Raritan, NJ - Project Coordinator

2011-01-17T11:13:00.000-08:00

Job Description:

Registering the 1k+ distributor rep email addresses to grant access to the distributor portal
Update distributor portal access as 1000+ distributor reps leave or newly hired
Ordering literature for shows/events/meetings
Processing Totality reports
Editing and distributing D-News newsletter periodically
Pulling periodic Box reports
Checking the Distributor hotline for messages
Updating the pricing spreadsheets as promos are rolled out and for annual price increase
Work with Dist counterparts to coordinate national and regional Distributor Meetings
Keeper of “Sold Instruments” by Dist
Help process credits and exceptions
Add to and delete as necessary (keeping current) Distributor Portal
To develop the project plan and to prioritize all tasks and activities in the plan
To publicize the project plan and activities with the project team
To track project activities against the project plan
To notify the project team with project agendas, upcoming meetings and subsequent minutes of the meeting
Provide day-to-day administrative and functional direction to teams to ensure project milestones are achieved
Monitor compliance with system development standards
Ensure issues are captured, tracked and resolved in a timely fashion
To be responsible for all matters relating to the coordination of the project tasks in the project plan
To support the project team by utilizing the necessary project systems and tools
To develop the necessary project reports and communications
To discuss progress and status to IM Manager Key Deliverables
Project Brief, Plan
Issue, Risk logs, meetings
PaRIS, TTS, GSR
Scorecards

REQUIREMENTS:

Experienced developing project plans and prioritizing all tasks and activities in the plans
Experienced publicizing the project plan and activities with the project team
Experienced tracking project activities against the project plan
Experienced notifying the project team with project agendas, upcoming meetings and subsequent minutes of the meeting
Experienced providing day-to-day administrative and functional direction to teams to ensure project milestones are achieved
Experienced monitoring compliance with system development standards
Experienced ensuring issues are captured, tracked and resolved in a timely fashion
Experienced being responsible for all matters relating to the coordination of the project tasks in the project plan
Experienced supporting the project team by utilizing the necessary project systems and tools
Experienced developing the necessary project reports and communications

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Skillman, NJ - Sourcing Manager III

2011-01-14T06:26:00.000-08:00

Job Description:

Drive contracting process from initial request of budget through execution of contractual document to include updating contract tracking database and managing change order process as necessary
May be responsible for leading cross-functional, multi-operating company teams through a comprehensive sourcing process
Provide advice to business partners and others within company related to signed agreements
Identify and select appropriate suppliers following departmental processes and manage specific external service provider (ESP) relationship(s)
Demonstrate value contribution through negotiated savings, competitive bidding, cycle times, etc.
Manage relationships with internal business partners as well as ESPs
Lead/conduct contract negotiations on terms and conditions of high-risk, complex, and potentially long-term agreements, and escalate specific points of contention on legal issues to appropriate legal staff
Work with the Law department as necessary to review, analyze, negotiate and advise business partners on contractual terms and conditions in order to reach acceptable language

REQUIREMENTS:

Must have demonstrated negotiating experience. Depending upon level would prefer anywhere from 5-10 years of experience in the pharmaceutical industry; drug development and procurement experience
Experience with contract research organizations as either a provider or user of services
For international candidates, a fluency in English (written and verbal) is required
10-15 years of experience, with at least 5 years procurement experience; direct knowledge of pharma industry and demonstrated experience in complex negotiations
Must be able to participate in the creation of high functioning interdependent partnerships with other sourcing and procurement groups, finance as well as internal project teams on an as needed basis
Must be able to develop interdependent partnerships with other sourcing and procurement groups, including but not limited to Finance
Experience as a user or provider of outsourced services
Knowledge of pharmaceutical R&D process, GLPs, GMPs or GCPs desirable
Required: Bachelor’s degree in a life science or business; additionally MBA, or C.P.M. (or equivalent)
Preferred: Highly advanced degree such as Ph.D., JD, Pharm. D
Must be able to work effectively in a matrixed environment while supporting specific teams and/or projects for business partners
Must demonstrate capability to be nimble and adapt to customer needs while balancing business priorities
Must be able to present/interface to/with Senior Management
Independently negotiate multiple complex situations (contracts, change orders, issue escalation)
Handle multiple high profile compound teams/projects
Must be able to read reports (press releases), determine impact to business and respond
Must possess global experience
Must have knowledge of drug development and experience in outsourcing clinical trial services, pre-clinical services and/or supplies to include the review and negotiation of budgets, scopes of work and contracts with suppliers such as Contract Research Organizations (CRO), central laboratories, etc.
Able to work independently as well as in a team environment and to make decisions based on analysis of supplier proposals and in partnership with internal business customers
Able to demonstrate creative ways to avoid/solve problems in order to manage the supplier relationship and not compromise any on-going study

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