Medical Writer
BioPhase
BioPhase Solutions specializes in recruiting top talented professionals for the San Diego County Scientific community. We are currently looking for a REMOTE Associate Director Medical Writer to work for a leading San Diego biotech company. Responsibilities
- Partner cross-functionally with Clinical Development, Biostatistics, and Regulatory teams to translate complex data into clear, high-quality regulatory documents
- Lead and/or contribute to the preparation of clinical and regulatory deliverables, including CSRs, IBs, protocols, briefing documents, and Module 2 summaries
- Drive consistency in messaging, structure, and scientific accuracy across documents, including facilitating data interpretation and review discussions
- Oversee and/or support document timelines, ensuring efficient review cycles, comment resolution, and on-time submission readiness
- Ensure all deliverables align with global regulatory standards (FDA, EMA, ICH), including QC review and collaboration with QA and Regulatory Operations
- Contribute to regulatory submissions (IND/NDA), including supporting responses to health authority inquiries
- At least 10+ years of medical writing experience within sponsor pharma or biotech
- Advanced degree required
- Demonstrated experience developing regulatory documents, with strong exposure to CSRs and IBs
- Extensive experience with owning, contributing to or supporting NDA regulatory submissions
- Background in small molecule drug development required
- Working knowledge of FDA, EMA, and ICH guidelines (including ICH E3 and E6)
- Strong ability to interpret scientific data and communicate it clearly in a regulatory context
- Proven ability to manage multiple deliverables and collaborate effectively in a fast-paced environment
- Proficiency in Microsoft Office and Adobe; familiarity with Veeva or eCTD systems is a plus
- Ability to work remotely while aligning with West Coast hours, with occasional travel as needed
- Full support and career-development resources to help you reach your potential
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Vacancy posted 1 day ago
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