Job Description

Primary Job Function: The primary function of the Manager Medical Writing is to provide medical writing expertise as well as project management support for periodic reports and signal evaluation reports. This includes: u2022 Accountability for the preparation and project management of assigned safety reports to ensure compliance. Further it is the responsibility of the Manager Medical Writing to deputize for the Head Periodic Reporting and Medical Writing. Core Job Responsibilities: u2022 Independently analyses pharmacovigilance safety data and produces written summaries and full reports based on applied clinical experience, current standards of medical care, and compliance with regulatory guidelines using scientifically based medical judgment. u2022 Performs job responsibilities in collaboration with the Global Medical Safety Experts, management, and cross-functional areas within Medical Affairs, Regulatory Affairs, Clinical Development and the Product Safety Teams. u2022 Responsible for the creation and oversight of project plans, which includes timeline management, preparation of business-critical regulatory documents, and the quality of key deliverables. u2022 Critically reviews and edits the written analyses of the Medical/Scientific Writer, assuring that documents are of the highest quality, appropriate for the designated audience, and reflect current medical standards. u2022 Participates in the identification, direction, and implementation of strategic business initiatives within the Periodic Reporting and Medical Writing Group. u2022 Assists with the development of training materials in regards to Periodic Reporting and Medical Writing. u2022 Mentors and coaches new Medical Writing staff and assists with onboarding and training plan. u2022 Proactively understands regulatory framework, trends & requirements related to Pharmacovigilance, clinical studies and global drug development. u2022 Actively contributes to minimizing patient and product risk by conducting pharmaceutical and medical assessment of information on drug risks including adverse reactions, drug interactions, toxicity and medication errors during periodic report preparation. This includes the consideration if safety data qualify as a new safety signal or as a new identified or potential risk, or may potentially alter any previous signal or risk assessment. u2022 Pharmaceutical advice and support of (Senior) Medical/Scientific Writer by provision of pharmaceutical expertise and assessment within the scope of report compilation. u2022 Supervision of pharmaceutical trainees. u2022 Position Accountability/Scope: u2022 Is accountable for the timely preparation of assigned periodic reports and signal evaluation reports. u2022 Works mostly independently, but will require some oversight/guidance. Minimum Education: u2022 Registered pharmacist. Minimum Experience/Training Required: u2022 Minimum 5 years industry experience in Pharmacovigilance, Strategic Medical Affairs or Clinical Development. u2022 Broad and proficient understanding of medical conditions and disease state entities, able to critically evaluate pharmaceutical/medical data. Good knowledge on pharmaceutical drug technology. u2022 Experienced professional operating within the international arena, and working across functional areas. u2022 Good negotiating skills, tact and diplomacy. Advanced knowledge of standard business procedures, very good project management skills, proficiency in the use of Microsoft Excel, Word, Power Point, Outlook, e-room technology, and good electronic Common Technical Document (eCTD) knowledge and formatting skills (e.g. ISI Write

foundit