The Sr. Director, Medical Writing is a leadership role that includes advising on, developing,and writing clinical and nonclinical documents for NDA/MAA submissions. This individual will provide medical writing and project management support for the programs and efforts of the clinical development group.
Provide interpretation and advice on regulatory guidelines (including NDA, MAA, and CTD) as they relate to specific requirements for regulatory submission documents.
Provide leadership within Medical Writing.
Regulatory documents include: Briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, clinical study protocols and amendments, informed consents, orphan drug applications, pediatric plans, interim and final clinical study reports, patient narratives, CTD clinical and nonclinical overviews and summaries, safety updates, and integrated summaries of safety and efficacy.
Advanced degree with 8+ years of experience.
Experience with preparation of drug substance and drug product sections of regulatory filing documents.
Thorough understanding of ICF and FDA guidellines.