We are currently seeking an accomplished and motivated individual for the role of Senior Manager, Medical Writing (Psychiatry/Neurology).
Job Duties and Responsibilities
- Develop strategic medical writing plans that align with program and project objectives, adhering to applicable guidelines (ICH, CFR, etc.) and SMPA templates and SOPs.
- Assess resource requirements to achieve regulatory submission document milestones and timelines as outlined in medical writing plans.
- Provide mentorship and guidance to Medical Writing staff (internal/external) to ensure document development aligns with medical writing plans.
- Perform senior-level review of regulatory submission documents prepared by Medical Writing staff (internal/external).
- Author and review documents for regulatory submissions (protocols, investigator brochures, clinical study reports, IND and NDA summary documents) in support of CNS clinical development programs.
- Collaborate with subject matter experts to shape document strategies and messages for accurate and concise presentation.
Education and Experience
- Minimum of Bachelor’s degree required
- Minimum 8 years of industry experience in biotech/pharma industry
- Extensive medical writing experience; document writing and review across the clinical development life-cycle from IND to NDA and beyond.
- Experience as a medical writing representative on cross-functional teams.