Responsible for providing support to the PEH Global Medical Affairs team, specifically : Researching literature databases, internal and external repositories to support the evaluation of Health Hazard Assessments and the benefit-
risk of Pfizer productsAuthoring documents that include support for major regulatory agency submissions, clinical overviews, health hazard assessments, listings and summaries of the results of the above research to the required standardReviewing the produced documents for relevance and compliance under the guidance of medical managerGMPE support and reviewing product promotional material for accuracy and alignment.
Reviewing promotional material to ensure it is accurate, truthful, not misleading and aligned with Core Claims, Common Technical and / or other regulatory documents
Ensuring delivery of all required activities within expected timelines and on budget
The Associate Medical Manager supports and partners with GMPE TA Leads by
Creating documents pertaining to clinical data, company data, published literature and other data to support the maintenance and defense of our products.
Some examples of such document include briefing documents to support meetings with regulatory agencies, clinical overviews and clinical efficacy section in support of PBRERs, ACOs, PSURs, ARs, product renewals health hazard assessments, critical review and analysis of the medical literature and responses to clinical and safety questions from regulatory authorities.
Providing expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
Assessing document requirements, gauging document complexity, and identifying information gaps or other potential issues.
In collaboration with the relevant GMPE TA Lead, the author proposes or contributes to strategies to resolve any identified issues.
Clinical and scientific medical writing, editing, and quality control review (QC) for regulatory documents including clinical study reports, safety narratives, protocols, protocol amendments, investigator brochures, and full submission documents for US and rest of world regulatory bodies.
Pharmacovigilance and drug safety writing including : Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSUR), and Development Safety Update Reports (DSUR).
Manuscript writing, including researching, organizing, compiling, interpreting, and quality checking various types of technical and / or medical information.
Reviewing and editing of scientific reports : pharmacokinetics, pharmacodynamics, cardiovascular reports, etc.
Medical communication writing including research and authoring of global medical standard response letters ("Dear Doctor" letters).
Creating slides, abstracts, training materials, and style guides, as needed for our clients and their diverse audiences.
Communicating with different clients and their departments for a coordinated structure of functions and workflow.
Adapting writing to different types of clients and audiences from the health care professionals and technical people to the consumer audience (general public).
Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams in a timely manner of any definite or potential deviations.
Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
Deliver assigned documents on or before deadline, alerting project teams in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
Understand relationships and dependencies between documents and analyses produced for regulators, e.g., RMP, DSUR, PBRER, and ACO.
Collaborate with other lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.