Associate Director Medical Writing (Fremont)
Meet Life Sciences, Fremont, CA, United States
Associate Director, Medical Writing (Hybrid - SF Bay Area)
We are seeking an experienced
Associate Director of Medical Writing
to lead the development of high-quality clinical and regulatory documents in support of complex drug development programs. This individual will play a key role in shaping document strategy, ensuring scientific accuracy, and driving cross-functional alignment across clinical, regulatory, and biostatistics teams.
This is a
hybrid role based in the San Francisco Bay Area . Relocation package is available.
Key Responsibilities
Lead the planning, authoring, and review of clinical and regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures (IBs), and submission documents
Serve as the medical writing lead on complex, multi-phase programs, including late-stage development and regulatory submissions
Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations to ensure aligned messaging and data interpretation
Drive document strategy and timelines to support IND, NDA, and other global regulatory submissions
Ensure all documents meet regulatory requirements, internal standards, and industry best practices
Manage external medical writers and vendors as needed
Provide mentorship and guidance to junior writers and cross-functional team members
Contribute to process improvements and development of templates, style guides, and best practices
Qualifications
PhD (or equivalent advanced degree) in life sciences, pharmacy, or a related field
required
8+ years of medical writing experience within biotech, pharma, or CRO environments
Demonstrated experience supporting complex clinical development programs and regulatory submissions (IND, NDA, BLA, etc.)
Strong expertise in authoring clinical and regulatory documents (e.g., CSRs, protocols, IBs)
Proven ability to manage multiple writing projects and timelines in a fast-paced environment
Excellent written and verbal communication skills, with strong attention to detail
Experience working in cross-functional teams and influencing without direct authority
Prior leadership or mentoring experience preferred
If this role sounds of interest, please reach out to tanya.kochan@meetlifesciences.com.
We are seeking an experienced
Associate Director of Medical Writing
to lead the development of high-quality clinical and regulatory documents in support of complex drug development programs. This individual will play a key role in shaping document strategy, ensuring scientific accuracy, and driving cross-functional alignment across clinical, regulatory, and biostatistics teams.
This is a
hybrid role based in the San Francisco Bay Area . Relocation package is available.
Key Responsibilities
Lead the planning, authoring, and review of clinical and regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures (IBs), and submission documents
Serve as the medical writing lead on complex, multi-phase programs, including late-stage development and regulatory submissions
Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations to ensure aligned messaging and data interpretation
Drive document strategy and timelines to support IND, NDA, and other global regulatory submissions
Ensure all documents meet regulatory requirements, internal standards, and industry best practices
Manage external medical writers and vendors as needed
Provide mentorship and guidance to junior writers and cross-functional team members
Contribute to process improvements and development of templates, style guides, and best practices
Qualifications
PhD (or equivalent advanced degree) in life sciences, pharmacy, or a related field
required
8+ years of medical writing experience within biotech, pharma, or CRO environments
Demonstrated experience supporting complex clinical development programs and regulatory submissions (IND, NDA, BLA, etc.)
Strong expertise in authoring clinical and regulatory documents (e.g., CSRs, protocols, IBs)
Proven ability to manage multiple writing projects and timelines in a fast-paced environment
Excellent written and verbal communication skills, with strong attention to detail
Experience working in cross-functional teams and influencing without direct authority
Prior leadership or mentoring experience preferred
If this role sounds of interest, please reach out to tanya.kochan@meetlifesciences.com.