The Sr. Director of Medical Writing will be responsible for working cross-functionally with internal team members and stakeholders to develop, implement, and maintain a standardized document development process for nonclinical and clinical documents, documents required for regulatory submissions to US and other global health authorities.
Works with the Nonclinical, Clinical, and Regulatory Affairs team members to prepare documents under strict timelines; documents may include pre-clinical study protocols and reports, clinical study protocols, protocol amendments, clinical study reports, scientific advice briefing documents, investigator brochures, safety updates, clinical summaries of safety and efficacy, and clinical overview
Provides leadership in planning and completing required documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and scheduled reports.
Manages external medical writing resources such as contract research organizations, document quality reviewers, and freelance medical writers, etc.
Advanced degree, e.g., PhD, PharmD or MD, with 8+ years medical writing experience in biotech/pharmaceutical industry
Demonstrated experience in preparing protocols, study reports, investigator brochures, safety updates, and regulatory documents, including regulatory submissions to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA)
Demonstrated ability to incorporate pre-clinical data into clinical and regulatory documents