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Keyskills / Must Haves:
PV, Pharmacovigilance, Drug Safety, Medical Writing
The Scientific advisor 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. Few examples of such documents 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 Leading writing teams, as lead medical writer, as needed. Coordinating the activity of other writers on the team and ensuring the quality and accuracy of their contributions. 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 Identify potential areas for process improvements and possible solutions, and communicate these to GMPE Therapeutic Area Lead and management. Clinical and scientific medical writing, editing, and quality control review (QC) for regulatory documents as required. 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). Providing strategic support to a variety of medical writing projects. Providing medical expertise and opinion. 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. Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. 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. Explain and defend data analyses before internal and external (including Regulatory Authority) audiences Develop and sustain constructive relationships within other Pfizer lines including country organizations. Identify potential areas for process improvements and possible solutions, and communicate these to GMPE TA Lead and management.