Senior Director, Medical Writing

Senior Director, Medical Writing

Job Summary:

The Senior Director, Medical Writing, will work with cross-functional teams to develop, write, and review clinical and regulatory documents, ensuring the documents are of high quality and comply with internal and external standards. This position reports to the SVP Regulatory Affairs & Quality, and is an onsite position based in San Diego.

Key Responsibilities:

• Lead the Medical Writing function to plan, prepare, write, edit, format, and finalize non-clinical, clinical, and regulatory documents. Documents will include, but are not limited to: IND, CTA, 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.
• Manage external writing vendors in the delivery of the Medical Writing book of work.
• Partner with regulatory affairs and cross-functional SMEs in developing and executing strategies for organizing and preparing documents for regulatory health authority submissions.
• Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams.
• Lead the development of templates, style guidelines, and SOPs for clinical documentation. 
• Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements.
• Effectively collaborate with Research & Development colleagues, including, but not limited to, clinical research, regulatory, safety, biostatistics, clinical operations, translational medicine, and discovery.
• Contribute to the future growth and development of the BlossomHill’s Medical Writing function, providing insights, experience and counsel to the SVP on strategic planning initiatives.

Qualifications:

• Ph.D. in Life Science related discipline or related field.
• 10 years of applicable regulatory affairs experience in a pharmaceutical or biotechnology industry role.
• Experience in oncology therapeutic areas required (solid tumor and/or hematology) 
• Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format. 
• Excellent organizational and project management skills.
• Ability to work effectively with other team members and departments at various levels, as well as with CROs and external consultants.
• Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.