Director, Medical Writer

Document Strategy & Authoring:
Lead the planning and authoring of high-priority clinical and regulatory documents, including Clinical Study Protocols, Investigator Brochures (IBs), and Clinical Study Reports (CSRs).

Regulatory Submission Leadership:
Drive the preparation of clinical components for regulatory filings (e.g., INDs, Briefing Books, and eventually BLA/MAA modules), ensuring a consistent scientific "voice" across all dossiers.

Quality Control & Document Integrity:
Own the quality control strategy for all clinical and regulatory documents, ensuring accuracy, internal consistency, data traceability, and alignment with statistical outputs, source data, and regulatory expectations.

Analytical Review and Scientific Narrative Development:
Translate complex datasets into clear, concise, and compelling scientific narratives that accurately reflect the data and support regulatory, clinical, and strategic objectives.

Cross-Functional Collaboration:

Partner closely with functions such as Clinical Development, Clinical Operations, and Regulatory Affairs to synthesize complex data into clear, submission-ready narratives.

Standards & Quality Control:
Establish and maintain company-wide document templates, style guides, and SOPs. Perform rigorous quality reviews of documents drafted by external partners to ensure scientific consistency.

Disclosure & Transparency:
Oversee clinical trial transparency activities, including the preparation of registry postings (e.g., Clinical Trials.gov) and results summaries for public disclosure.

Culture Shaper:
Actively contribute to building a high-performance, collaborative environment. You will lead with a "no-ego," humble approach, acting as a supportive partner to other functional leads to ensure document excellence