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Tuesday, December 28, 2010

Norristown, PA - Java Developer

Job Description:
  • The Application Developer is responsible for understanding the requirements of the business units and supporting the project and support teams by implementing technical systems based on those requirements
  • In support of that responsibility, the Application Developer will work with the project and support teams, as necessary, to ensure the technical solutions meet the business needs, and are developed and implemented with high quality
  • The scope of responsibility for the position includes project support
  • The Java Developer responsibilities will include, but are not limited to, the following:
  • Perform all Phases of Software Development including requirement analysis, designing, development planning, coding, and testing the systems based on the business needs
  • Solid grasp of Software Development lifecycle methods, and conventions, including but not limited to Test Driven Development, Source Code Management, Continuous Integration and Dependency Management
  • Familiar with and Adhere to common Software Development Best Practices
  • Must be able to work well with Technical and non-technical resources
  • Interacts directly with Business Clients
  • Able to work Independently or as part of a Small Team
REQUIREMENTS:
  • Bachelor’s degree Computer Engineering, Computer Science, Engineering or equivalent hands-on work experience
  • 5 - 7 years of experience with J2EE and Java Technologies
  • Solid Development Experience using Servlet, JSP, JDBC, JSTL, XML & XSLT
  • Solid Coding Experience using Web-presentation technologies including HTML, CSS, JavaScript & AJAX
  • Good Development Experience with Spring and Advanced Spring MVC Experience
  • Hands on Experience with Oracle
  • Experience using Base SAS and SAS Macros
  • Experience using SAS Integration Technologies
  • Strong Experience using Eclipse
  • Good understanding of Design Patterns including J2EE Patterns
  • Strong Experience with Automated Build Utilities like ANT
  • Experience using Hibernate
  • Strong Experience using JBoss
  • Experience with Clear Case/SVN
  • Familiar with unit testing frameworks including JUnit
  • Sun Certified Programmer
  • Working Experience Required in Full Software
  • Development Life Cycle (SDLC) for at least one or two Projects 
Preferred Skills: • Self-starter will hit the Ground running
• Creative problem Solving Skills
• Excellent oral and written communication skills and the ability to clearly articulate to all project members and stakeholders
• Good grasp of industry best practices in enterprise-class software development, agile methodology

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Wednesday, December 22, 2010

New York, NY - Administrative Assistant

Job Description:
Provides full-range of administrative support to include:
  • Manages multiple Outlook calendars with expertise
  • Plans and coordinates a variety of meetings and events, such as staff meetings (including recording of action items) and a variety of recurring events with other groups inside and outside of the company when necessary
  • Prepares and edits reports and presentations using Microsoft Office software
  • Organizes and maintains files
  • Coordinates and manages travel arrangements and prepares expense reports
  • Fields incoming telephone calls and replies to routine inquiries
  • Provides project management assistance when necessary
  • Expedites flow of work, and initiates follow-up when necessary, particularly when supervisors are traveling
  • Orders supplies and equipment
  • Cooperates with other administrative assistants in maintaining an efficient workroom
  • Serves as back-up administrative support for any member of the team when necessary
REQUIREMENTS:
  • Ariba   Desired 1-3 Years of experience
  • Document Scanning Experience – Desired 1-3 Years
  • GCE   Desired 1-3 Years of experience
  • MS Outlook   Desired 1-3 Years of experience
  • MS PowerPoint   Desired 1-3 Years of experience
  • MS Word   Desired 1-3 Years of experience
  • Pegasus   Desired 1-3 Years of experience
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New York, NY - Medical Affairs Coordinator

Job Description:
Support Global Oncology Medical Communications including:
  • Proactively assists the Global Medical Communications group in the processes, reporting and communications related to planning and execution of priority global oncology conferences throughout the year
  • Complete activity templates and grids, internal communications, spreadsheets and PowerPoint updates and liaise with our conventions group regarding all plans pertaining to identified core congresses
  • Assist in the budget process, including creating projects and contracts for approval, ensuring timely invoicing from external vendors, following up as needed, and creating and maintaining a budget status report
REQUIREMENTS:

  • 1-3 years of advanced experience using MS Office (Word, Excel, PowerPoint, Outlook)
  • Undergraduate degree strongly desired
  • Financial or some budgeting knowledge/experience
  • Excellent organization skills ensuring timely updating of status reports and templates and follow-up as needed
  • Proven ability to independently prioritize and manage projects
  • Resourceful in investigating questions and issues and an ability to solve problems with limited supervision
  • Highly responsible, proactive and a self-starter
  • Communicates effectively both verbally and in writing with superiors, peers, and colleagues inside and outside the company
  • Exhibit a professional manner in dealing with others regardless of their approach and frustration level
  • Excellent proof reading and attention to detail
  • Ability to handle confidential information, without exception
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Skillman, NJ - Buyer II

Job Description:
  • Sr. Supply Planner needed
  • Responsibilities include working with multiple cross-functional partners to ensure the supply, managed inventory, and high customer service
  • Analyzes inventory levels weekly to determine needs to rebalance, coordinates with multiple supply points for upcoming production, works with distribution centers to ensure timely inbounding, and collaborates with trade customization partners on build and deployment of displays
REQUIREMENTS:
  • Ideal candidate will have supply chain background, minimum 5 years of experience, be detail-oriented, and have SAP ECC 6 experience
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Chesterfield, Missouri - BTxPS eLN Contract Position

Job Description:
This IT Technical role will help facilitate the creation, testing and validation activities to create business objects in the BTxPS Symyx Notebook system

Major Role Responsibilities:
  • Facilitate the creation of business objects in the Symyx Notebook eLN
  • Test the business objects in appropriate system environments against business requirements
  • Create and manage supporting documentations about the creation and validation of Symyx Notebook business objects
  • Migrate business objects to the production system as needed
  • Assist in support of the deployment of the Symyx Notebook system to the BTxPS users
REQUIREMENTS:
  • Laboratory Information Management Systems (LIMS)   Desired 1-3 Years of experience
  • Business Process Management, Desired 1-3 Years of experience
  • Change Control Functions, Desired 1-3 Years of experience
  • Product Testing/Verification, Required 1-3 Years of experience
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Tuesday, December 21, 2010

Spring House, PA - Research Associate I

Job Description:
  • Recruiting for a Research Associate in Lead Generation Biology to be located in the eastern Pennsylvania area
  • Develops medicines and treatments that improve the health and lifestyles of people worldwide
  • A research associate level scientist is needed to support the Lead Generation team by performing cellular and biochemical assays
  • Assays include: radioligand binding, label free whole cell kinetics, fluorescent and luminescent calcium mobilization (FLIPR), and cAMP
  • These studies with support high throughput screening, compound safety and selectivity, target validation, and assay development
  • The associate will: use automation to screen compounds; culture and plate cells; perform analysis of data; upload data, record assay parameters in a research notebook; and, generate reports
REQUIREMENTS:
  • A B.S. in Biology, Cell Biology, Molecular Biology, Microbiology, or Biochemistry, and at least 3 years of experience in the pharmaceutical industry
  • Demonstrated experiences are required in all aspects of invitro plate based techniques including: assay development, dosing of compounds, and data analysis
  • Cell culture experience is essential
  • Communication skills, dedication to quality work, ability to multitask, as well as an aptitude toward timeline-driven responsibilities will help the candidate succeed in our team
  • Experience validating and screening with cell based kinetic assays, binding assays, cAMP, and viability assays are helpful
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New York, NY - Project Manager

Job Description:
  • The person in this role will support the “Brand Loyalty Strategy” project sponsored by EPBU leadership team
  • The role requires working closely with the project sponsor and project leader. It involves taking complete ownership of various aspects of project management routines such as:
  • Creation and maintenance of detailed project plan in Microsoft Project
  • Identifying dependencies and their impact on start / finish dates and critical path
  • Pro-actively identifying project bottlenecks and alerting relevant stakeholders
  • Tracking and reporting progress over a period of time
  • Attending all relevant project meetings and documenting agreements
  • Discussions with stakeholders to identify sub-tasks, assign ownerships and timelines
  • Consistent follow-up and coordination to gauge progress vis-à-vis tasks, timelines and ownerships
  • Identifying and communicating risks and organizing meetings to proactively mitigate roadblocks
  • Constant communication (verbal and written) with 25-30 stakeholders to ensure the project remains on track
  • Periodic status updates to project team and executive leadership team (including project leader and sponsor)
  • On-demand report generation from MS Project (Gantt charts, critical path, etc.)
REQUIREMENTS:
  • 4-7 years of experience in Project Management
  • Strong critical thinking and problem solving skills
  • Very strong written and verbal communication skills (English)
  • Team player with strong collaboration skills
  • Organized and detail oriented
  • Self- motivated individual
  • Strong with Microsoft Project
  • Good Microsoft Office skills (mainly Power Point)
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Richmond, VA - Raw Material Associate

Job Description:
  • The Raw Materials Associate will provide analytical raw material testing support and assist with non-test related lean lab management duties
  • Work to ensure that laboratory activities adhere to applicable SOPs, FDA regulations, and government regulations
  • Help schedule and prepare for daily testing activities Support periodic compliance and safety checks
  • Exercise good laboratory practices and demonstrate professional conduct when interacting with site personnel and support representatives
REQUIREMENTS:
  • Experience working in the Pharmaceutical and Manufacturing environments is desired
  • Undergraduate degree is required
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Monday, December 20, 2010

Wilmington, DE - Safety Advisor

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 profile of the company's 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 insure 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 time frames
  • 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
  • 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
  • Initiates and volunteers for special projects
  • Demonstrates leadership capabilities at target level or above
REQUIREMENTS:
  • 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)
  • 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
  • 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
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Bridgewater, NJ - Clinical- Biostat/SAS

Job Description:
A statistician is being sought for the following:
  • Consultant will be writing statistical analysis plans, analyzing clinical study data, contributing statistical sections to a final study report (including table and listing appendices, report results sections, graphs, etc.) and IND Annual Safety Reporting
  • Candidate will also work with the team to resolve reporting issues, trouble-shooting of complicated analysis rules, proactive identification of problems, and attend study meetings
REQUIREMENTS:
  • Must have excellent communication skills and work well in a study team environment that includes SAS programmers, data managers, clinical, and regulatory colleagues
  • Experience coordinating work assignments with a CRO is a plus, but not necessary
  • Pharmaceutical research oncology experience in the US is a plus, but not necessary
  • A PhD or MS in Statistics with at least 3 years pharmaceutical experience in an FDA regulated environment covering Phases II-IV
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New Brunswick, NJ - Pro Active Sourcing – Legal

REQUIREMENTS:
  • Attorney must have at least 3-5 years of TRANSACTIONAL experience (not litigation) in a mid to large law firm drafting and negotiating contracts and MUST be admitted in NJ or have a NJ limited in-house license
  • Will work on the following type agreements: non-disclosure, confidentiality, master purchasing, and on off agreements
  • Person will draft and negotiate the agreements and will work with internal and external parties to complete the contracts
  • Will support about 20 internal clients
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Wilmington, DE - Project Manager

Project Management Certified
  • Project Bridge is a major part of the Finance Fast Forward program
  • It is a significant change in the way we do transactional finance (P2P, T&E, etc.) through which we will move to these services being delivered by a combination of companies
  • Project Bridge is a global project currently operating in 6 regions across the world
  • The North America region is one of the later ones
  • The role is to act as the local project manager for this project, working closely with the Global Transition Director, the Global PMO Director and the newly appointed NA Head of Transactional Finance
Description: 
  • This is a key role that is responsible for project managing the successful delivery of in scope NAM/Medi regional transit ion related activity for Project Bridge - the transition of the current, diverse in-house transactional finance landscape, to the new globally led, regionally based, combined in-house/out-sourced shared services organization
  • The principal deliverable is the successful delivery of the NAM/Medi transitions delivery of this is through managing and overseeing transitions to external service provider centers, including contributing to the design and implementation of a robust and efficient retained organization
  • The role is a combination of overseeing/directing and hands on delivery
The role holder will:
  • Maintain close links to the Global Bridge team, in particular the Global Transition Director, and ensure that regional plans are consistent with the overall objectives of the Global program
  • Provide day to day direction to the Regional Transition team to ensure successful and on time transitions
  • Work with the Sr Director GTF Operations NAM, NAM / Medi management, Transition team, and Global Program team to define transition plans, methodology and resourcing needs
  • Deliver a successful knowledge transfer transition to the service provider
  • Manage the day to day interface with the service provider transition team
  • Support the Sr Director GTF Operations NAM in establishing and operating an effective regional transition governance framework, including stakeholder reporting mechanisms.
  • Manage the day to day relationship with the IS lead on regional transitional implementations
  • Provide guidance to and consult with the HR, Change and Communications teams on transitional implementation matters
  • Establish clear roles and responsibilities, and ways of working with regional management 
  • Establish a good network to other regional transition teams to ensure optimal best practice sharing
Impact on business results:
  • The successful transition of activity to our service provider is a key enabler of the Finance Fast Forward program and the Finance Operating model
  • It is the biggest change that the company’s Finance have undertaken since merger
  • If successful it will deliver a majority portion of the overall savings target that has been set
  • The success of this role will be measured in terms of (i) successfully delivering on the business case for transition to the new operating model, and (ii) delivering on-time and high quality transitions with minimum adverse impact upon service levels
Major Responsibilities:
  • Successful regional transition through partnership, discipline, risk planning and a proven process
  • Day to day coaching of the Regional transition team and other Program resources (HR, Comms, IT Finance etc.) to ensure smooth, on-time and to quality transitions
  • Work closely with the Service Provider Transition team to ensure transitions run to plan and time
  • Ensure the transition methodology is appropriate, to deliver successful transitions, including compliance with contractual obligations
  • Lead and own standard project management discipline related to regional transition e.g. planning, reporting, risk management, best practice reviews, cost management and stakeholder analysis and management
  • Develop and maintain regional risk and issue registers throughout the transitions, managing escalations as required
  • Provide monthly (or as required) updates to Program Steering Committee on progress of transitions
  • Support the Sr Director GTF Operations, Global Transition Director and PMO
  • Prime Areas of Complexity and Type of Problems Solved
  • The prime complexity will be the project and change management required to transform the organization while the operation continues to function in its legacy state
  • A close second will be management of the conflicting issues
  • Problems solved will range from detailed day to day transition related issues to complex organizational change issues
Relationship Management:
  • Key stakeholder relationships include GTF Senior Management Team members, senior NAM and Medi Finance Management, IS partners, other GTF members, Change Management/Communications team and service provider staff
  • Work with the wider Transactional Finance group in the following areas:
  • Regional SSC Heads
  • Global Process Owner teams
  • Finance and Business Performance Management Manager
  • Other members of the Bridge Team
  • Relevant IS Groups
  • Global Head of Transactional Finance
REQUIREMENTS:
  • Degree or equivalent professional qualification
  • Extensive organizational transformation experience
  • Significant work experience in Finance related activities
  • Energetic and self-motivated
  • Strong written and verbal communication skills
  • Oral and written fluency in Business English
  • Ability to use a range of influencing techniques and awareness of cultural differences
  • Experience of global technology implementations (Ariba, ERP, T&E)
  • Proven ability to manage multiple projects/tasks effectively
  • Proven experience of change management
  • Demonstrated success working in a team environment
  • Demonstrated success building cross-functional global networks and stakeholder management
  • Strong numerical and analytical skills
  • Experience of implementing significant business change across different national and business boundaries
Preferred:
  • Experience of implementing transitions into a Finance & Accounting SSC
  • Specific industry and process experience
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Thursday, December 16, 2010

Wilmington, DE - Sr. Project Manager

Job Description:
  • The Strategic Project Manager is responsible for the successful planning, managing, and execution of key Commercial initiatives
  • In this role, the individual will interface with Commercial Leadership and stakeholders from Brand Teams, Sales, and the Commercial Functional Areas to understand and solve complex business challenges
  • The individual will ensure delivery of project outcomes that are high quality, timely, and cost effective and will serve as a champion for improvement opportunities
  • In addition, the individual should strive to ensure that the Commercial Operations Strategic Project Management Team embodies the behaviors and characteristics of a high-performance organization
REQUIREMENTS:
  • Experienced quickly understanding business challenges and champion the needs of a variety of Commercial stakeholders
  • Experienced providing clarity to nebulous business issues and developing actionable solutions that drive positive business outcomes
  • Experienced developing clear and accurate project work plans to facilitate effective project management and prioritize/manage project work
  • Experienced soliciting active engagement from project stakeholders, subject matter experts, and others in the organization as appropriate
  • Experienced managing Commercial projects to ensure high-impact, timely, and on-budget delivery
  • Experienced providing direction and leadership to cross-functional project resources (both internal and external)
  • Experienced facilitating timely and effective decision making
  • Experienced anticipating, identifying and resolving business risks/issues
  • Experienced developing impactful project communication plans
  • Experienced developing effective frameworks, presentations, and communications (written and oral)
  • Experienced defining and monitoring key performance indicators/metrics to measure initiative successes
  • Experienced creating process designs to streamline and simply business processes
  • Experienced enabling best practice sharing and consistent use of commonly defined methods, processes, tools, and templates
  • Experienced fostering integration across organizational initiatives
  • Experienced proactively identifying business improvement opportunities
  • Experienced utilizing Lean Six Sigma concepts in managing projects
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Wednesday, December 15, 2010

Collegeville, PA - Publication Specialist

Job Description:
  • Responsible for coordinating the development and implementation of a products publication plan thereby supporting the products Publication Sub-Committee
  • Oversees compliance with the company’s publication policies and SOPs
  • Works collaboratively with representatives from the BUs, Research, Legal, Quality Standards, Procurement, Business Technology, Finance, Contract and Outsourcing and external vendors
Publication Policies & Procedures
  • In collaboration with Legal, responsible for enforcement of publishing policy standards (ICMJE guidelines, the company’s Corporate Integrity Agreement, HCP Engagement SOP) and communication of any policy standards changes
  • Serve as coach to PSC members on publication planning and execution
Vendor & Budget Management
  • Collaborate with Procurement around vendor selection, contracting and ongoing monitoring of vendor relationships
  • Work in a vendor facing role to communicate key information and requirements to Publication Agencies
  • Work with Publication Agencies to educate them on established Publication policies and procedures
  • Take a lead role in facilitating issue resolution
  • Establish and manage assigned product publication budgets within WW and US Medical
  • Partner with Finance to maintain/monitor publication budget forecasts.
Publication Planning
  • Coordinate the development of a publication plan for a number of products within the established business planning cycle
  • Using publication planning/product knowledge and experience, contribute to the development of the publication plans
  • Serve as a consultant to the PSCs on selection of appropriate journals and congresses for data submissions
  • Support the efficient execution of the plan in adherence with policies and procedures
  • Monitor and evaluate overall publication plan goals and objectives by product and make recommendations for improvements where needed
  • Work closely with the Medical Leads for each product to ensure successful development and execution of the publication plan
Technology/Processes
  • Accountable for the effective use of a standardized publication planning tool
  • Identify and drive metrics, tool refinement, process improvement and sharing best practices to further enhance efficiency
REQUIREMENTS:
  • Bachelors level education in Health Sciences
  • At least 2 years in developing and managing publication planning within the pharma industry
  • Strong interpersonal, communication and negotiation skills
  • Vendor management experience
  • Project management experience
  • Experience in a matrix environment
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Tuesday, December 14, 2010

New York, NY - Safety Analysis and Medical Writing

Job Description:
  • The PSSR Analyst role provides documents clearly summarizing a drug’s risks and benefits
  • In conjunction with the project team and with colleagues in Worldwide Safety Strategy (WSS) and Worldwide Safety & Regulatory Operations (WRSO), will contribute to understanding and communicating risk and risk/benefit, through essential written deliverables
  • These include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Periodic Safety Update Reports, NDA Periodic Adverse Drug Experience Reports, etc.), responses to regulatory questions, post-marketing safety assessment for potential changes to labeling documents
  • Specific tasks are assigned according to the incumbent’s expertise, training and capacity
  • In producing these, the analyst applies expert knowledge, analytical skills, knowledge of clinical and regulatory guidance and scientific and medical literacy
  • These deliverables will enable the company’s product teams to optimize the chance of license approval with a commercialisable label and appropriate maintenance of post marketed products
  • Delivery of some of these documents may be by matrix management of, or collaboration with, other analysts, epidemiologists and authors in WSRO, WSS, or Worldwide Development
Primary Responsibilities:
  • Consult with the project or product teams to determine the key messages for documents with consideration of proposed labeling statements
  • Partner with project or product team members in preparing commissioned deliverables
  • Establish and chair document working groups comprised of authors and subject matter experts (SMEs) from the project or product teams, as necessary
  • Ensure high quality written presentations of integrated clinical data compliant with regulations, ICH guidelines, and corporate SOPs for review and assessment, implement systems and processes to achieve this and suggest process improvements
  • Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management
  • Develop and sustain constructive relationships within WSS, WSRO and with Worldwide Regulatory Strategy, Development Operations, Clinical Sciences, Country Offices medical departments, Marketing and other stakeholders
REQUIREMENTS:
  • Scientific/medical academic background (MSc/BSc with clinical training/experience), or equivalent, ideally with experience in drug development, clinical pharmacology, and/or pharmacoepidemiology within the pharmaceutical industry, regulatory agencies or academia
  • Knowledge of US and international regulatory/safety regulations and guidelines
  • Experience working with the safety databases
  • Strong organizational skills and ability to prioritize multiple projects and meet deadlines
  • Extensive experience in Safety, Regulatory or Clinical Development and business experience
  • Effective influencing and negotiating skills
  • Fluency in oral and written English; knowledge of additional language(s) an advantage
  • Excellent presentation skills
  • Strong risk management expertise, ability to demonstrate strategic thinking and solid analytical skills
  • Effective influencing and negotiating skills
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Pearl River, NY - Micro QC Scientist

Job Description:
  • As a Micro QC Scientist, you will perform chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components as well as some specialized techniques
  • You will identify basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems and participate in the investigation to resolve and correct
  • Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Pfizer standard operating procedures, and approved license requirements
  • Results are compared with specifications and documented
  • You will have mastered most or all of fundamental technical and quality concepts
REQUIREMENTS:
  • Water Sampling/Testing in a Laboratory Setting Required 1-3 years of experience
  • Applicants MUST have knowledge of Microbial Water Testing, Bioburden
  • Knowledge of Endotoxin and Microbial Limits is a HUGE plus
  • Applicants MUST have 3 -4 years SOLID Pharma experience (not school work or internships)
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Kalamazoo, MI - Legal Affairs Assistant

Job Description:
  • The successful candidate will have primary responsibility for supporting the Pfizer Animal Health Legal Department and VMRD with an emphasis on coordination of the contracting process, including processing, receipt, execution, filing, retention and overall document management, and ensuring records are maintained and updated on a continuous basis
  • In addition, this person will assist in updating pre-existing contracts to ensure compliance with FCPA policies
  • The Legal Affairs associate will provide the interface between US VMRD and PAH Legal, and between US VMRD and external parties with whom agreements are being executed
REQUIREMENTS:
  • Certified Legal Secretary/Assistant  Desired 1-3 Years of experience
  • Paralegal   Certifications Desired 1-3 Years of experience
  • Secretarial Assistant   Desired 1-3 Years of experience
  • Associate Degree   Required
  • High School Diploma or Equivalent   Required
  • Undergraduate Degree   Desired
  • 3 - 5 Years of experience General Administrative Experience Desired
  • 1 - 3 Years of experience Legal Department Experience Required
  • 3 - 5 Years of experience Legal Department Experience Desired
  • Excellent Oral Communication Skills Required 1-3 Years
  • Ability to multi-task
  • Attention to detail
  • Ability to prioritize and work under a tight schedule
  • Fluency with the Microsoft Office software Suite
  • Knowledge of legal terminology and principles
  • Corporate and departmental operating policies and procedures
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Skillman, NJ - Scientist I

Job Description:
  • Conducts experiments, analyzes data
  • Develops solutions to complex problems, which require the regular se of ingenuity and creativity with minimal advice/supervision
  • Actively participates in problem solving activities and researches issues customers
REQUIREMENTS:
  • BS degree in science, mathematics, engineering, or other related technical field
  • Must have 1-5 years of experience, with experience in performing statistical analysis
  • Requires ability to analyze complex data and integrate multi-disciplinary feedback
  • Must have excellent math skills
  • Basic or advanced computer and database management skills
  • Excellent communication and interpersonal relation skills
  • Statistical and analytical problem solving
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Monday, December 13, 2010

Cambridge, MA - Sr. Statistical Consultant

Job Description:
  • Consultant will be writing statistical analysis plans, analyzing clinical study data, contributing statistical sections to a final study report (including table and listing appendices, report results sections, graphs, etc.) and IND Annual Safety Reporting
  • Will also include working with the team to resolve reporting issues, trouble-shooting of complicated analysis rules, proactive identification of problems, and attendance at study meetings
REQUIREMENTS:
  • Must have excellent communication skills and work well in a study team environment that includes SAS programmers, data managers, clinical, and regulatory colleagues
  • Experience coordinating work assignments with a CRO is a plus, but not necessary
  • Pharmaceutical research oncology experience in the US is a plus, but not necessary
  • A PhD or MS in Statistics with at least 3 years pharmaceutical experience in an FDA regulated environment covering Phases II-IV
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Andover, MA - ARD QC-Analyst

Job Description:
  • Tests the stability of pharmaceutical Active Pharmaceutical Ingredients (APIs) and Drug Products used in clinical studies to determine how the quality varies with time under the influence of a variety of environmental factors such as temperature, humidity and light exposure thereby enabling recommended storage conditions and associated
  • Retest and use periods to be established for the purposes of patient safety and product performance
  • ARD = Analytical Research and Development
REQUIREMENTS:
  • MUST HAVE AT LEAST A BACHELOR'S DEGREE
  • Laboratory Analytical Equipment :Required 1-3 Years
  • Laboratory Analytical Techniques :Required 1-3 Years
  • Laboratory Biochemical Techniques : Desired 1-3 Years
  • Laboratory Capillary Electrophoresis (CE) : Desired 1-3 Years
  • General Laboratory Protein Chemistry Skills  :Desired 1-3
  • Laboratory High Performance Liquid Chromatography (HPLC)   :Laboratory Desired 1-3 Years
  • Laboratory Information Management Systems (LIMS)   :Desired 1
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Norristown, PA - Java Developer

Job Description:
  • The Application Developer is responsible for understanding the requirements of the business units and supporting the project and support teams by implementing technical systems based on those requirements
  • In support of that responsibility, the Application Developer will work with the project and support teams, as necessary, to ensure the technical solutions meet the business needs, and are developed and implemented with high quality
  • The scope of responsibility for the position includes project support
  • Perform all Phases of Software Development including requirement analysis, designing, development planning, coding, and testing the systems based on the business needs
  • Solid grasp of Software Development lifecycle methods, and conventions, including but not limited to Test Driven Development, Source Code Management, Continuous Integration and Dependency Management
  • Familiar with and Adhere to common Software Development Best Practices
  • Must be able to work well with Technical and non-technical resources
  • Interacts directly with Business Clients
  • Able to work Independently or as part of a Small Team
REQUIREMENTS:
  • Bachelor’s degree Computer Engineering, Computer Science, Engineering or equivalent hands-on work experience
  • 5 - 7 years of experience with J2EE and Java Technologies
  • Solid Development Experience using Servlet, JSP, JDBC, JSTL, XML & XSLT
  • Solid Coding Experience using Web-presentation technologies including HTML, CSS, JavaScript & AJAX
  • Good Development Experience with Spring and Advanced Spring MVC Experience
  • Hands on Experience with Oracle
  • Experience using Base SAS and SAS Macros
  • Experience using SAS Integration Technologies
  • Strong Experience using Eclipse
  • Good understanding of Design Patterns including J2EE Patterns
  • Strong Experience with Automated Build Utilities like ANT
  • Experience using Hibernate
  • Strong Experience using JBoss
  • Experience with Clear Case/SVN
  • Familiar with unit testing frameworks including JUnit
  • Sun Certified Programmer
  • Working Experience Required in Full Software Development Life Cycle (SDLC) for at least one or two Projects
Preferred Skills:
  • Self-starter will hit the Ground running
  • Creative problem Solving Skills
  • Excellent oral and written communication skills and the ability to clearly articulate to all project members and stakeholders
  • Good grasp of industry best practices in enterprise-class software development, agile methodology
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Bridgewater, NJ - Sr. Statistical Consultant

Job Description:
  • Consultant will be writing statistical analysis plans, analyzing clinical study data, contributing statistical sections to a final study report (including table and listing appendices, report results sections, graphs, etc.) and IND Annual Safety Reporting
  • Will also include working with the team to resolve reporting issues, trouble-shooting of complicated analysis rules, proactive identification of problems, and attendance at study meetings
REQUIREMENTS:
  • Must have excellent communication skills and work well in a study team environment that includes SAS programmers, data managers, clinical, and regulatory colleagues
  • Experience coordinating work assignments with a CRO is a plus, but not necessary
  • Pharmaceutical research oncology experience in the US is a plus, but not necessary
  • A PhD or MS in Statistics with at least 3 years pharmaceutical experience in an FDA regulated environment covering Phases II-IV
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New Brunswick, NJ - Global Recruiterdurepurv specific

Job Description:
  • Contract Recruiting Consultants to manage the recruiting process for assigned positions as a member of the company’s 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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Ft. Washington, PA - Graphic Designer I

Job Description:
  • Assigns component part numbers to labeling components
  • Initiates and tracks artwork creation and corrections thru graphics vendors
  • Upload of artwork into EDM system for proofreading/approval
  • Initiates and tracks approvals of artwork thru the McNeil labeling process
  • Follows up as necessary with approvers who are late in approving labeling/packaging documentation
  • Provides graphics input into labeling and packaging documentation, including scope control documents, BOM set up forms, and material specifications
  • Communicates project timelines and status for assigned projects
  • Manages color standard development, approval, and distribution to incoming QA inspection sites
REQUIREMENTS:
  • Experienced in “task oriented” graphic designs that involve tracking and labeling
  • Two (2) years of experience in Graphic Design
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Thursday, December 9, 2010

Chelmsford, MA - Ethernet Product Specialist

Job Description:
  • Voltaire (NASDAQ: VOLT) is a leading provider of scale-out computing fabrics for data centers, high performance computing and cloud environments
  • Voltaire’s family of server and storage fabric switches and advanced management software improve performance of mission-critical applications, increase efficiency and reduce costs through infrastructure consolidation and lower power consumption
  • Used by more than 30 percent of the Fortune 100 and other premier organizations across many industries, including many of the TOP500 supercomputers, Voltaire products are included in server and blade offerings from Bull, Fujitsu, HP, IBM, NEC and SGI
  • Founded in 1997, Voltaire is headquartered in Ra’anana, Israel and Chelmsford, Massachusetts

Candidate’s primary responsibilities will be to perform the duties below:
  • Act as subject-matter expert on the Voltaire Ethernet product line and serve as authoritative consultant to customers and partners
  • Prioritize incoming issues as well as being able to resolve time-critical situations reliably & professionally
  • Manage customer escalations and be an active member of the escalation team
  • Provides mentorship/guidance on 10GbE technology to clients, partners, and employees
  • Provide training and support to our channels and customers’ as required
  • Communication driver between Field and Corporate on technical issues
  • Assist with the implementation and installation of Voltaire technology at customer sites and systems integrator lab environments
  • Problem reporting, escalation, replication, and resolution management
  • Troubleshoot technical issues and problems using analytical methods to identify root cause
  • Problem analysis and data gathering including packet trace in support of escalated issues
  • Project management of complex installations
  • High level of direct customer interaction, often working independently with customers
  • Understand customer environments where HPC/Scale-Out/Cloud solutions are being deployed
  • Understand tools for installing, tuning, and monitoring
REQUIREMENTS:
  • 4-year degree from an accredited university or college in Computer Science, or Electrical or Computer Engineering
  • 5 - 10 years of experience in the computer industry (HPC industry experience highly desirable) in a hands-on technical position
  • Travel required up to 30%
  • Candidate must be a polished professional, able to present technical solutions to a wide variety of audiences including engineers and business managers
  • Candidate must be able to develop comprehensive solutions to customer problems including project management of complex installations
  • Candidate must be very organized and be able to prioritize and multi-task easily with limited supervision
  • Excellent communication and presentation skills including the ability to present in front of large audiences
  • A positive attitude, a desire to learn new technologies and the ability to handle interruptions in a very challenging environment
  • Solid knowledge of Networking – MUST
  • Sr. level knowledge of common Ethernet networking protocols and applications such as: L2 switching, TCP/IP, IGMP, BGP, OSPF, ISIS, MPLS, 10GigE, IPSEC, L2Tp tunneling, VPNs, SNMP, Security Protocols. – MUST
  • Proven experience with configuring, troubleshooting and monitoring network devices such as switches and IP routers- MUST
  • Knowledge and experience with working on Linux/Unix systems including installing, configuring and administrating - Preferred
  • Networking vendor’s certification (Cisco, Lucent, Juniper etc.)- Advantage
  • Clustering technologies including Upper Layer Protocols (ex. MPI)
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New York, NY - Contract Recruiter - Clin. Develop. Medical

Job Description:
  • Provides essential HR support in the delivery of the recruitment process in designated client area(s), thereby enabling line managers to achieve the manpower elements of their strategic business plans as well as their day to day operational staff resource objectives
  • Responsible for the full-lifecycle recruiting process
  • Partner with the site Recruiting Manager to implement effective recruitment strategies as well as participate in the selection process including assessing candidate applications, screening, interviewing and recommending finalists
  • Ensure compliance with federal and state regulatory requirements along with company policies
  • 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
REQUIREMENTS:
  • 3 – 5 years of experience with the full-lifecycle recruiting process
  • Undergraduate degree
  • Understanding federal and state regulatory requirements
  • Experienced with competitive intelligence databases
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Norristown, PA - SR. SECURITY & COMPLIANCE ANALYST

Job Description:
  • The ITS Security & Compliance department is responsible for the oversight and coordination of all security and compliance-related functions for the Information Technology & Services (ITS) division
  • The ITS Security and Compliance Analyst plays a key role in carrying out this responsibility, by maintaining a strong relationship with departments which support key information technologies such as applications, databases, networking devices, operating systems, SAN and storage devices
  • The analyst is assigned to one or more departments which support these key technologies and is responsible for ensuring that all cyber assets in their assigned areas maintain an adequate level of security
  • The analyst is also responsible for helping their assigned departments gain a clear understanding of internally and externally-defined compliance requirements
  • These security and compliance related responsibilities will be executed within the framework developed and maintained by the ITS Security & Compliance Manager, the ITS Security & Compliance Lead and Analysts in order to ensure consistent application of security and compliance requirements across the ITS organization Additionally, the ITS Security and Compliance Analyst will be called upon to serve as a member and/or leader of assigned various projects and initiatives related to the functions and responsibilities of the ITS Security & Compliance Department as required
  • In order to effectively perform these responsibilities, the ITS Security & Compliance Analyst must have effective communication skills, a strong understanding of information security fundamentals and principles, a deep understanding of the NERC CIP and SAS/70 compliance requirements and a knowledge of the area of information technology they are assigned to support
REQUIREMENTS:
  • Experience working as a system administrator for the AIX, Linux OR Windows operating system
  • Experience facilitating the development and documentation of security policies, standards and procedures for the AIX, Linux OR Windows platforms
  • Experience with identifying, evaluating and developing plans to mitigate security risks and vulnerabilities for the AIX, Linux, OR Windows platforms
  • Strong written and verbal and communications skills
  • Strong attention to detail
  • Experience working in an area of information technology that was subject to compliance with externally defined requirements.  If the candidate does not have compliance experience, that is OK, as PJM is willing to train on the compliance piece
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Bridgewater, NJ - Recruiter

Job Description:
  • Responsible for partnering with the organizations they support
  • Ownership/Accountability for all openings in client family
  • Ownership for obtaining/building detailed position information
  • Ownership for all metrics relating to the recruitment and recruiting process of client group  and  measured against targets
  • Educate client groups on recruiting/staffing processes Document/track recruiting activities in system
  • Coach managers on the selection process
  • Source, screen and interview candidates
REQUIREMENTS:
  • Must be self-motivated, present well and be able to develop relationships with both managers and candidates
  • Bachelor degree preferred with minimum of 5 years relevant experience
  • Ability to navigate through change and demonstrate flexibility as organizational needs shift
  • 2-3 years of solid recruiting experience
  • Must develop and implement creative sourcing strategies to identify talent
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New London, CT - BusOps Business Administrator

Job Description:
  • Provides full-range of administrative support to include:  manages multiple Outlook calendars with expertise
  • Plans and coordinates a variety of meetings and events, such as staff meetings (possibly including recording of action items) and a variety of recurring events with other groups inside and outside of the company when necessary
  • Prepares and edits reports and presentations using MS Office software; organizes and maintains files
  • Coordinates and manages travel arrangements and prepares expense reports
  • Fields incoming telephone calls and replies to routine inquiries
  • Provides project management assistance when necessary
  • Expedites flow of work, and initiates follow-up when necessary, particularly when supervisors are traveling
  • Orders supplies and equipment
  • Cooperates with other administrative assistants in maintaining an efficient workroom; serves as back-up administrative support for any member of the team when necessary
REQUIREMENTS:
  • Possesses strong knowledge/background in thoroughly reviewing, compiling, facilitating and organizing data
  • Excellent communicator both verbally and written; will need to be proactive in working well with others to organize data
  • Resource must have strong knowledge in MS Excel and Outlook; preferred basic experience in SharePoint
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Huntingdon Valley, PA - Life Scientist I

Job Description:
  • This medical lab professional will accession, process, analyze and report blood samples for multiple clinical trials using CELLSEARCH® rare cell technology
  • Other functions include performance of proficiency testing and  quality control procedures, assist with inventory, data entry, instrument maintenance and other lab procedures as necessary
  • Additional responsibilities will include use of  database management through the use of Excel spreadsheets
REQUIREMENTS:
  • BS in Biology or Medical Technology
  • Minimum 5 yrs Clinical Lab experience
  • Experience with CELLSEARCH® CTC testing preferred
  • Experience with clinical trials preferred
  • Willing to work second shift (4pm to midnight)
  • Experience and knowledge on Excel
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Wednesday, December 8, 2010

Raritan, NJ - Global Recruiter

Job Requirements:
  • 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
  • Must have a demonstrated ability to apply judgment to ambiguous or out-of-policy situations
  • Excellent interpersonal communication, customer-service and organization skills required
  • 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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Groton, CT - External Vendor Inventory Mgmt Coordinator

Job Description:
  • Interface with Supply Chain Coordinators for Inventory Discrepancy Resolution
  • Interface with Import/Export for Release and Delivery Issues
  • Daily Communication with External Vendor Inventory Management personnel
  • Creation of Material ID’s in Clinicopia (Inventory System) and Follow through to approval
  • Creation of Lots in Adjustments and Lot Resolution in Clinicopia
  • Review of Completed Documentation
  • Loading Receipt Data into GDMS
  • Interface with Quality for Lot Release
  • Interface with Quality at the Vendor for Investigation/GMP Issues
  • Interface with Manufacturing with Delivery Issues
  • Interface with Purchasing with Shorts/Expiry dating/Damage
  • Interface with Analytical for transit excursions
  • Interface with Quality to expedite issue resolution
  • Issue Tracking
  • Metrics Tracking data input
  • Coordinate with Internal IM for Issue Resolution
  • Assist Packaging Coordinators with a Plan of Action for Re-Packs
  • Escalation of Issues to the Appropriate Line
  • Coordination of the Packaging of Bulk Grants
  • Transfer Receipts in CSDS (Pfizer Finished Goods Distribution System)
  • Creation and distribution of daily reports
  • Multiple System access and input of data
REQUIREMENTS:
  • High attention to Detail
  • Work Independently
  • Excellent Customer Service Skills
  • Problem Solving
  • Good Communication Skills
  • Multi-Tasking
  • Follow Through
  • Microsoft Office: Excel, Access, Word
  • Materials Expert – desirable
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Tuesday, December 7, 2010

Athens, GA - Project Coordinator

Job Description:
  • To provide general support and coordination of activities for the Technical Services group (which includes the active pharmaceutical ingredient and chemical impurity Reference Standards Program), as well as to the overall Scientific Affairs department
  • This support includes reference standards daily operations, logistics and material movement, documentation support, purchasing support, DEA coordinator duties, SAP support, and other duties as required by the Scientific Affairs department
  • In addition, this role will interact with external and internal customers with regard to reference standards supply and qualification, material movement, and customer inquiries
  • Day to day oversight of the Reference Standards Program:
  • Technical resource for active pharmaceutical ingredient and chemical impurity reference standards
  • Create documents such as batch records, worksheets, reports and CoAs
  • Maintain inventory control via SAP
  • Schedule and coordinate scientific experiments for the replenishment (chemical synthesis & analytical qualification) of reference standards and materials in consultation with supervisor
  • Package and ship materials (including high potency compounds) to internal/external customers
  • Track reference standards budget, provide financial analysis, and competitor price evaluation
  • Communicate with DEA regarding quota and material movements to maintain compliance
  • Communicate with Customer Service to meet customer requirements
  • Implement continuous improvement processes to the Reference Standards Program
  • Other duties as needed to support the Reference Standards Program
  • Summarizes and conducts preliminary data interpretation, including the use of statistical packages and standard databases
  • Records all information obtained in the laboratory according to established procedures and specifications Maintain and provide notebooks, records and documentation that are current, legible, readily understood, complete, accurate and verifiable as required or requested
  • Ensures that records and raw data are properly retained
  • Assists in preparation of technical reports and other documents that record data or results
  • Issue, update and review Scientific Affairs documents as needed
  • Serve as DEA coordinator for the Scientific Affairs department; participate in DEA audits
REQUIREMENTS:
  • Minimum requirements include a Bachelor’s degree (B.S.) in Chemistry or related area of study and 1-3 years of work experience using basic laboratory skills or chemical analysis
  • Knowledge of chemical manufacturing and GMP regulations highly preferred
  • An equivalent combination of education, training, and experience may be used to meet the minimum qualifications
  • Knowledge of cGMP regulations is required
  • Use computer software and customize programs to meet business needs, including word processing and mathematical applications
  • MS Excel knowledge required
  • Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production
  • Must be able to work with people, influencing their output and work behavior
  • Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production
  • Ability to perform under stress in cases of emergency, critical or hazardous situations
  • Must have the ability to make independent decisions within general guidelines and to work under minimum supervision
  • Must be highly organized and have the ability to prioritize multiple tasks to meet business needs
  • Role will work a traditional M-F work schedule
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Horsham, PA - Project Coordinator

Job Description:
  • Serve as liaison between project leads (on- and off-site), external service providers (ESPs), North America Pharmaceuticals Scientific Affairs (NAPSA) contracting, attorneys to problem-solve and expedite contract execution
  • Submit request for agreements (RFA) to initiate International Contract Database (ICD) and NAPSA contracting process
  • Facilitate-ESP negotiation of contract language appropriate to business need and overall project scope
  • Track timelines and status of all projects from RFP phase, through contract negotiation, healthcare compliance (HCC) review, and financial approval to assignment of purchase order (PO)
  • Track status of project deliverables against planned milestones
  • Identify process improvements and initiate action plans to reduce cycle time
  • Enter transactions (TOTALITY) and obtain necessary approvals including supporting project leads on document collection and fair market value (FMV) assessment for contract pricing committee (CPC) reviews
  • Support  request for proposals (RFP) and collection from service providers
  • Partner with other project  coordinators to implement best practices across Health Economics & Outcomes Research (HECOR) NAPSA
  • Ensure updated information entered into HECOR project tracker
  • Assist with systems harmonization and transition of documents and related information from QUEST to ICD and/or SMART electronic filing system
  • Perform other ad hoc requests as needed
  • Budget Management (in collaboration with senior administrative assistant)
  • Coordinate planning and tracking of project budgets
  • Work closely with finance to ensure timely information is provided
  • Solicit accurate quarterly close estimates
  • Monitor to ensure quarterly and year-end close are met
  • Perform other related ad hoc requests as needed
  • Supportive Roles
  • Reconcile issues with POs, ARIBA, invoices and AP as needed
  • Create purchase orders (ARIBA)/obtain necessary approvals as needed
  • Performing supplier maintenance using ARAVO system as needed
  • Communication Planning
  • Compile and update key documents
  • Year-to-date publication list
  • Monthly reports of project highlights
  • Evidence Maps
  • Archive final documentation (e.g., RFP, proposal(s), protocol, statistical analysis plan, study report, publications into SMART system
  • Perform other related ad hoc requests as needed
REQUIREMENTS:
  • Understand NAPSA contracting process including knowledge of legal, budgetary, and scope of work issues
  • Understand NAPSA’s fiscal process and basic accounting principles
  • Working knowledge of MS Office Suite, TOTALITY, RECAP, and ARIBA
  • Excellent skills in collaboration, influencing, communication (oral/written)
  • Advanced degree, B.S. or higher
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New York, NY - Data Reconciliation & Research Clerk

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
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Morris Plains, NJ - Knowledge Management Consultant

Job Description:
  • This position intends to fill a Knowledge Management Consultant role for Business Technology Infrastructure under the Process Standardization Team
  • The selected candidate, in cooperation with project leads, will manage and drive the Knowledge Management (KM) consolidation deployment effort and work with BTI/BT SMEs to enable deployment and adoption of the KM tool and process
  • The selected candidate will execute on project management methodologies, coordinating and driving work of the core and extended teams and interactions with stakeholders and sponsors, to result in one consolidated KM solution for Business Technology
  • The selected candidate will have a working knowledge of the IT environment, Knowledge-centered Support (KCS) methodology and ITIL best practices in order to fully understand the project and deliverables
  • Partner with BTI SMEs to deploy KM
  • Hold meetings with identified SMEs to identify current knowledge portals and knowledge needs
  • Initiate and Coach SMEs on bulk migration efforts of current knowledge from other homegrown KB portals (hand off scripting to BT KM administration team)
  • Enroll SMEs into KM system (WBTs, determine access to specific portals)
  • Assist SMEs in identifying appropriate taxonomy (should map to ServiceCenter Taxonomy)
  • Coach SMEs on KCS Methodology Solve/Evolve Loop 
  • Define task owners working with service areas and providers
  • Tracks and reports progress relative to deployment activities and demonstrated results
  • Communicates project status, milestones and issues to the project manager
  • Applies effective project management methodologies and control techniques
  • Works independently and with deployment team members to deploy the Knowledgebase and KM methodology across BTI/BT
  • Manages project critical path and scope
  • Reviews and verifies deliverables
  • Identify and implement additional KM sharing opportunities within assigned BTI group PM efforts of specific BTI/BT deployment area
  • Hold weekly meetings to discuss progress (adoption rate, KM content migration, metrics and quality reviews, Feedback)
  • Provide Webex Demos of KM process and tools
  • Coordinate with BT KM content team to ensure proper SMEs are identified 
  • Communicate successes and recognition to KM PM
  • Lead KM SME team meetings and sub-meetings
  • Create meeting minutes
  • Update Actions log
  • Project administration
  • Project time tracking and administration
  • Project issue and risk tracking
  • Project document management including filing, retrieval, and standards enforcement
REQUIREMENTS:
  • Minimum: Bachelor of Science degree in information systems, information management, or related field
  • Excellent knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint) and Microsoft Project
  • Preferred: MBA and/or MS, PMP/PMI Certification
  • Other: KCS Methodology and ITIL Foundation v3 certification, Six Sigma Certification, Business Management /Leadership Training experience
  • 5 years of progressive experience in IT and program/project management
  • Experience with training and coaching knowledge management methodology (KCS preferred)
  • Strong interpersonal skills, with demonstrated ability to manage geographically distributed teams, as well as the ability to operate in a politically sensitive environment
  • Demonstrated success in managing customer relationships
  • Excellent communication skills (both written and verbal) with the ability to build relationships, influence outcomes, and prioritize/resolve problems
  • Demonstrated ability to interact comfortably with all levels of management and colleagues
  • Experience in working with complex processes, systems and customers preferred
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Monday, December 6, 2010

Wilmington, DE - SAS Programmer

REQUIREMENTS:
  • Number of Years Work Experience Required: 3
  • Degree is not required but would need equivalent years of experience instead
  • Competent SAS Programmer with experience on both UNIX and Windows
  • Data management and data management programming preferred
  • Experience with data collection standards preferred
  • CDISC (Clinical Data Interchange Standards Consortium)knowledge preferred
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Andover, MA - Automation Assistance

Job Description:
  • The scientist will be responsible for routine sample analysis using immunoassay techniques
  • Additional responsibilities include oversight of instrument installation and organization of a new laboratory space
  • The scientist will be trained on automated instruments and will support methods run on the instruments and participate in the maintenance of the instruments
REQUIREMENTS:
  • Bachelor's degree required
  • Candidates should have 1-2 years of experience with ELISA, routine sample analysis
  • Experience in automated lab a plus
  • Bioanalysis   Desired 1-3 Years Base/Entry
  • Immunoassays (RIA, ELISA)   Required 1-3 Years
  • Liquid Handling Robotics   Desired 1-3 Years
  • Quantitative Bioanalysis   Desired 1-3 Years
  • Reading Plates   Required 1-3 Years
  • Sample Analysis   Required 1-3 Years
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Madison, NJ - Senior CMC Technical Writer

Job Description:
  • The primary responsibility is to prepare Modules 2 and 3 in the Common Technical Document format (CTD) for the Chemistry, Manufacturing, and Controls sections of Marketing Authorizations for new product submissions and preparation of variations
  • The incumbent will work with the technical groups at manufacturing/packaging and release sites to ensure that GMP-related documentation is complete and appropriate for the authoring of various sections of the submissions
  • The Technical Writer will liaise with the CMC Strategist to effect review and approval of all submission components with the applicable review teams
  • In addition, the Technical Writer will provide required assistance to the Regional CMC Conformance Hubs to ensure assembly and transmission of the final submission to the company’s Country Offices to meet project deadlines
  • Assist the CMC Strategist in the evaluation of Regulatory Change Controls when necessary
  • Under the direction of the CMC Strategist, collect required technical documents to author submissions according to the defined Table of Contents
  • Author all submissions in the CTD format in English using approved PREDICT templates
  • Ensure the timely preparation of submission components in alignment with pre-determined timelines
  • Ensure the timely review and approval of submission components with the pre-determined review teams, including, but not limited to, plant technical groups, QA, Regional CMC Conformance Hubs, Regional and PCO Regulatory Managers
  • Ensure compliance with all applicable SOPs governing the Regulatory Change Management processes
  • Strictly adhere to all project timelines and immediately raise issues that may delay these timelines to the supervisor
Key Decisions:
  • Participates in decisions and provides input regarding the adequacy, accuracy, interpretation, and clarity of technical information/reports prepared by plant functional groups to support submission-related activities
  • Consults with appropriate groups (as required) regarding the acceptability of submission documentation
  • Obtains the appropriate regional / central regulatory management input as required
Key Interfaces:
  • PCO and  Regional Regulatory
  • Site Quality Operations Groups
  • Site Technology Groups (Tech Services, Tech Ops)
  • External Partners
REQUIREMENTS:
  • Bachelor's degree in Chemistry, Pharmacy or a related science field plus 4-6 years of relevant experience industrial experience in the healthcare industry
  • OR MS/PhD/Pharm.D. plus 3-4 years of relevant industrial experience in the healthcare industry
  • Minimum of 1-2 years of hands-on CMC authoring experience for initial registrations and post marketing variations is mandatory
  • Comprehensive understanding of CTD format and content is mandatory
  • Experience working in the Pharmaceutical manufacturing industry (preferably in QA, Technical Services, Operations, manufacturing plant or Research & Development), knowledge of pharmaceutical development process, cGMPs and regulatory requirements is required
  • Excellent English writing and oral presentation skills mandatory
  • Prior experience with Consumer Healthcare Products highly desired
  • Prior experience managing projects is preferred
  • Regulatory experience with both US and international countries submission types is highly preferred
Key Competencies:
  • Project Management
  • Organization and Time Management
  • Communication (Verbal, Written, and Interpersonal)
  • Influence/Negotiation
  • Collaboration
  • Relationship Building
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Friday, December 3, 2010

Memphis, TN - Fixed Asset Temp

Job Description:
  • Quarterly Reporting for smaller companies.
  • Auditing of Genpact disposals and acquisitions, ensuring proper documentation and approval was provided.
  • Process fixed asset activity, reconcile various general ledger accounts, and research and resolve discrepancies to ensure
  • Accounting transactions are in compliance with Pfizer accounting policies and GAAP.
  • Work collaboratively with Pfizer capital and finance leaders to ensure large scale capital projects are closed and recorded timely and accurately (will require strong reconciliation, problem solving, analytical, and communication skills).  
  • GENX large data files and prepare monthly journal entries.
  • Monitor FA system functionality and perform maintenance as needed to ensure data integrity (Daily/Weekly/Monthly) impacted by external feeds and various purchasing system.
  • Handle capital asset policy and procedure inquiries and ad hoc reporting requests; provide periodic customer/site training.
  • Research and resolve discrepancies and technical accounting questions
  • Assist FA Supervisor as needed; participate in or lead special projects that require creative and analytical skills.
  • Insure customer needs and relationships are fulfilled and enhanced through proactive involvement and interaction
  • Involvement in projects.
  • Develop and assist in automating data retrieval and analysis techniques
  • Maintain complete and accurate standard operating procedures and support control documentation requirements (SOX). 
  • Provide support for miscommunications between the site and Genpact.
  • Support Genpact colleagues is their day to day processes.
  • Customer support and the complexity of fixed asset accounting transactions will be high with certain locations Supports activities relating to internal corporate accounting and finance systems
  • Ensures compliance with accounting standards and internal policies
REQUIREMENTS:
  • Experienced in monitoring FA system functionality and perform maintenance as needed to ensure data integrity (Daily/Weekly/Monthly) impacted by external feeds and various purchasing system
  • Experienced handling capital asset policy and procedure inquiries and ad hoc reporting requests; provide periodic customer/site training
  • Experienced researching and resolving discrepancies and technical accounting questions
  • Experienced assisting FA Supervisor as needed; participating in or lead special projects that require creative and analytical skills
  • Experienced insuring customer needs and relationships are fulfilled and enhanced through proactive involvement and interaction
  • Involvement in projects
  • Experienced developing and assisting in automating data retrieval and analysis techniques
  • Experienced maintaining complete and accurate standard operating procedures and support control documentation requirements (SOX)
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Andover, MA - Bench Scientist

Job Description:
  • We are seeking applications from qualified individuals interested in the development and support of biopharmaceutical purification processes
  • The successful candidate will work in a multi-disciplinary team environment focused on development of large-scale processes suitable for the manufacture of protein therapeutics
REQUIREMENTS:
  • Qualifications include BS in engineering / chemistry/biology or biochemistry with 0-2 years of work experience (or MS with 0-2 years) and a strong academic track record
  • Previous work in a biotechnology laboratory is desirable
  • Candidates must have strong technical, problem solving and computer skills
  • The candidate will work independently in a multi-project environment where strong communication skills, both written and oral are essential
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Thursday, December 2, 2010

Memphis, TN - FSC Business Analyst

Job Description:
  • Administer Computron, Oracle, and SAP User Security processes such as provisioning, termination, and periodic reviews
  • Maintain Chart of account in Computron as a member of this support team
  • Provide end user support via hotline and service requests on Computron as a member of this support team
  • Assist in coordination of the company, monthly financial closing, ensuring all deadlines are met and information is transmitted to the corporate consolidation system on time
REQUIREMENTS:
  • Pharmaceutical Experience is not required but would be a plus
  • A BS Degree or equivalent in Accounting is required
  • Three to five years accounting systems experience required
  • Audit experience is preferred
  • Prior experience with Oracle eBS, SAP, or Computron is preferred
  • Proficiency in Accounting systems and Financial applications is essential
  • Advanced proficiency in Microsoft Access required
  • Excellent ability to assimilate client requests and deliver results in a manner which meets the client’s needs efficiently and accurately
  • Ability to work independently and prioritize multiple tasks
  • Strong accounting, communication, interpersonal, and organizational skills a must
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Spring House, PA - Chemist I

Job Description:
  • The bioanalytical chemist will have expertise in cell culture and the use of high performance liquid chromatography (HPLC) and mass spectrometry (MS) for determination of drug and endogenous metabolites in biological matrixes
  • The candidate will perform quantitative analyses using HPLC/MS on a wide variety of compounds using established assay protocols
  • The primary responsibility is to provide analytical support for early drug discovery projects
  • The candidate will prepare reports to communicate results with the therapeutic teams
REQUIREMENTS:
  • The position requires a solid knowledge of basic wet chemical methods (i.e., preparing stock solutions, setting up assays, and so on), cell culture and HPLC/MS operation
  • Good oral and written communication skills are required
  • Education requirements include a B.S. degree in analytical chemistry with 1-3 yrs experience
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