Sr. Manager, Medical Writing
Artiva Biotherapeutics
June 29, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Job Title: Sr. Manager, Medical Writing
Responsibilities:
- Author clinical and regulatory documents (protocols/amendments, Investigator Brochures, lab manuals, annual reports such as DSUR/IND annual reports, clinical study reports, and clinical sections of regulatory submissions like IMPDs/INDs/CTAs/BLAs/MAAs as applicable).
- Write, edit, and collaborate with clinical development teams to ensure scientific accuracy, internal consistency, and compliance.
- Manage documents with consistent style to support regulatory dossier review.
- Apply standards and best practices for document review/completion/approval; ensure adherence to applicable regulations and guidelines.
- Develop/maintain medical writing standards (templates and style guides).
- Review/edit functional-area draft sections for compliance with established standards.
- Author and coordinate written responses to health authority questions and deficiency letters with Regulatory Affairs.
- Plan, write, edit, and review abstracts, posters, oral presentations, and manuscripts.
- Coordinate/prioritize multiple deadlines; create and maintain project timelines.
- Perform quality review to ensure program standards are met.
Qualifications:
- Bachelor’s degree required; MS/PhD/PharmD (or equivalent) preferred in Biology/Chemistry/Biochemistry or related life sciences.
- 4+ years preparing clinical and regulatory documents, including late-stage experience (e.g., CSRs, BLA/MAA clinical sections).
- Experience supporting cell therapy, gene therapy, or biologics strongly preferred.
Skills/Knowledge:
- Ability to author/edit clinical-regulatory documents with minimal supervision.
- Working knowledge of ICH/GCP and FDA/EMA expectations and editorial standards.
- Preferred: health authority interaction support (briefing documents and responses).
- Strong analytical, written/editorial, organizational skills; ability to manage competing deadlines; collaborate with cross-functional and outsourced teams.
Benefits:
- Medical, dental, vision; Group Life Insurance; LTD; 401(k); EAP; FSA; PTO; company-paid holidays (including year-end week).
Base salary: $165,000–180,000 (varies by skills/experience).
Responsibilities:
- Author clinical and regulatory documents (protocols/amendments, Investigator Brochures, lab manuals, annual reports such as DSUR/IND annual reports, clinical study reports, and clinical sections of regulatory submissions like IMPDs/INDs/CTAs/BLAs/MAAs as applicable).
- Write, edit, and collaborate with clinical development teams to ensure scientific accuracy, internal consistency, and compliance.
- Manage documents with consistent style to support regulatory dossier review.
- Apply standards and best practices for document review/completion/approval; ensure adherence to applicable regulations and guidelines.
- Develop/maintain medical writing standards (templates and style guides).
- Review/edit functional-area draft sections for compliance with established standards.
- Author and coordinate written responses to health authority questions and deficiency letters with Regulatory Affairs.
- Plan, write, edit, and review abstracts, posters, oral presentations, and manuscripts.
- Coordinate/prioritize multiple deadlines; create and maintain project timelines.
- Perform quality review to ensure program standards are met.
Qualifications:
- Bachelor’s degree required; MS/PhD/PharmD (or equivalent) preferred in Biology/Chemistry/Biochemistry or related life sciences.
- 4+ years preparing clinical and regulatory documents, including late-stage experience (e.g., CSRs, BLA/MAA clinical sections).
- Experience supporting cell therapy, gene therapy, or biologics strongly preferred.
Skills/Knowledge:
- Ability to author/edit clinical-regulatory documents with minimal supervision.
- Working knowledge of ICH/GCP and FDA/EMA expectations and editorial standards.
- Preferred: health authority interaction support (briefing documents and responses).
- Strong analytical, written/editorial, organizational skills; ability to manage competing deadlines; collaborate with cross-functional and outsourced teams.
Benefits:
- Medical, dental, vision; Group Life Insurance; LTD; 401(k); EAP; FSA; PTO; company-paid holidays (including year-end week).
Base salary: $165,000–180,000 (varies by skills/experience).