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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