regeneron
Tarrytown, NY
Regeneron is seeking a highly motivated Manager, Scientific Writing to supervise regulatory submission drafting activities for preclinical pharmacokinetics (PK) content with a focus on genetic medicines, eg, siRNA and gene therapy products. In this role, you will develop and manage a team of PK writers within Regeneron’s Scientific Writing group, which overall is dedicated to the drafting of submission documents with nonclinical content (PK, Toxicology, and Pharmacology) as well as select documents supporting CMC and Clinical Pharmacometrics content. A Typical Day Looks Like: Coach writers on preparation of regulatory submission documents with PPK content with a focus on genetics medicine throughout the entire document life cycle including content development, drafting, reviews, comment reconciliation, quality control, formatting, adherence to style guides, approval, and upload to file repositories. Develop processes and guidance documents for preclinical PK submission...