Title: Senior Manager, Medical Writer
Location: Fully Remote
Job Type: 12-month contract w/extension possibilities
Position Summary:
The primary responsibilities of a Senior Manager Medical Writer at CLIENT'S include, but are not limited to, leading key medical writing projects and activities across therapeutic areas and preparing (under some supervision) scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics. These types of scientific and regulatory documents can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (i.e., integrated summaries of safety and efficacy, product labeling, and summaries and overviews of nonclinical and clinical information). The Senior Manager Medical Writer has a general range of experience in pharmaceutical medical writing and clinical/pharmaceutical development and knowledge of current regulatory guidelines.
Primary Responsibilities:
- Acts as medical writing point person for production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions.
- Participates in and contributes to the development of the submission communication strategy for a product.
- Interprets and summarizes data from biostatistical summary tables and listings accurately, precisely, and concisely into narrative text.
- Liaises with internal groups, i.e., Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations, Translational Research and External Innovation, and R&D Management to obtain necessary information and to ensure the timely implementation of activities related to the production of reports.
- Interacts with and oversees and reviews the work of other medical writers, including freelance/contract medical writers and agencies, with support from Head of Medical Writing.
- Fosters innovation and improvement related to medical writing processes and documents, with support from Head of Medical Writing,
- Other responsibilities as assigned.
