Pharmacovigilance Medical Writing Manager

Job description

Pharmacovigilance Medical Writing Manager  Position Summary The Pharmacovigilance Medical Writing Manager is responsible for writing and editing a variety of scientific and medical content, including but not limited to the following: Aggregate Reports, Risk Management Plan(RMP), Risk Evaluation and Mitigation Strategies (REMS), protocols, investigator brochures, clinical study reports, responses to regulatory questions and other clinical and regulatory documents, in accordance with applicable Good Clinical Practice requirements and legislation. The medical writer will work independently to review Client documents and author the reports. The medical writer will collaborate with the PV Project Leads and other relevant functions to ensure accuracy and clarity of all relevant content. Essential: To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. Essential Functions Statement(s): - Proactively contribute to development and implementation of Medical Writ...