Experienced Medical Writing Consultant for Early-Clinical Stage Auto-Immune Biotech

Logistics Manager Level 20 hours per week for 6 months Remote Travel Requirements: N/A Hourly rate: $70 - $145 About We are a clinical-stage pharmaceutical company that is developing the next generation of antibody-based therapies to transform the treatment of autoimmune diseases and oncology indications. We are looking for an experienced Medical Writer for supporting our upcoming IND/CTN submissions and need someone to assist with regulatory and other key document preparation and protocol writing. Our ideal consultant has a self-starter personality, expertly manages timelines, and ideally has prior experience in autoimmune studies.

Responsibilities

• Prepare, edit, and finalize clinical regulatory briefing packages for the FDA and TGA, with input and support from regulatory, medical and other cross functional teams
• Leading the drafting and finalizing of key documents supporting IND and CTN submissions
• Creating key document templates (synopsis, protocol, IB) and writing/document authoring (with cross functional support and input) of such documents for early stage studies, and manage timelines, collaborative review and finalization process, including development of the strategy and timelines for document preparation and review process.
• Review work of other functional expert content writers for accuracy, quality, focus, and adherence to format and stylistic requirements

Ideal Candidate

• 8+ years of regulatory medical writing experience in biotech industry, experience with FDA and TGA (Australia) is required.
• Extensive experience writing protocols and protocol amendments and IND/CTA/CTNs, especially for early stage, first in human studies.
• Experience writing other common clinical and regulatory documents including IBs and IB updates, Module 2 & 3 documents, CMC writing, IMPDs, clinical study reports (CSRs), BLA modules, annual reports [eg, DSUR], briefing packages, etc.
• Auto-immune experience preferred.
• Experience supporting biologic therapeutics strongly preferred.
• Sponsor side experience is preferred.

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