Ad/Director, Medical Writing

Our client, a rapidly-growing life science company focused on the treatment of psychiatric and neurological conditions, is currently seeking an Associate Director/Director of Medical Writing to join their team. This person will be responsible for developing regulatory documents and providing strategic and tactical support for the preparation and submission of critical regulatory documents (e.g., IND, NDA, briefing books) and responses to health authority information requests.

Responsibilities:

• Assist in the development of templates, style guidelines, and SOPs for clinical documentation
• Serve as lead contact for interactions with cross-functional teams contributing to the preparation of submission materials, including project and timeline management activities
• Ensure final documents adhere to standard operating procedures (SOPs), good clinical practice (GCP), and the International Council on Harmonization (ICH)
• Coordinate the internal review of documents
• Plan, prepare, write, edit, format, and finalize non-clinical, clinical, and regulatory documents including, but not limited to; INDs, NDAs, CTAs, non-clinical summaries, clinical protocols, clinical study reports, investigator brochures, updates to regulatory submissions, briefing books, annual reports/development safety update reports (DSURs), manuscripts and posters
• Effectively collaborate with Research & Development colleagues, including, but not limited to, clinical research, regulatory, safety, biostatistics, clinical operations, translational medicine, and discovery
• Assist in developing and implementing strategies for preparing documents for regulatory health authority submissions
• Perform quality control review of medical writing documents

Qualifications:

• Prior experience in medical writing for CNS regulatory filings is a strong plus
• Able to work independently, meet deadlines, demonstrate effective use of time, and handle multiple assignments simultaneously
• Knowledge of regulatory guidance relevant to medical writing
• Prior experience in a small company environment preferred
• Proficient in Microsoft Word, Adobe Acrobat, Microsoft PowerPoint, and other standard software used for data analysis and writing of regulatory documents
• Exceptional attention to detail, with a keen eye for accuracy and appropriate specificity
• 5+ years of Medical Writing experience in the biopharmaceutical industry
• BS or equivalent degree in life sciences. Advanced degree (MS or Ph.D.) preferred
• Understands the clinical drug development process, including clinical trial design, operations, and results analysis

If you are interested in this position, please send your resume to [email protected]