Sr. Manager, Medical Writing (Remote)
Artiva Biotherapeutics
August 12, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Job Summary:
The Sr. Manager, Medical Writing supports clinical development, regulatory submissions, and scientific communications across Artiva Biotherapeutics. Reporting to the Associate Director, Medical Writing, authors clinical and regulatory documents and collaborates cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Pharmacovigilance. No direct reports.
DUTIES/RESPONSIBILITIES:
- Author clinical and regulatory documents, including protocols/amendments, Investigator Brochures, lab manuals, annual reports (e.g., DSURs/IND annual reports), clinical study reports, and clinical sections of regulatory submissions (IMPDs, INDs, CTAs, and BLAs/MAAs as applicable).
- Write, edit, and collaborate to ensure scientific accuracy, internal consistency, and compliance.
- Manage documents and apply consistent formatting/style for dossier review.
- Use standards/best practices for review, completion, and approval; ensure adherence to applicable regulatory requirements.
- Develop/maintain medical writing standards (templates and style guides).
- Review/edit documents authored by functional area representatives.
- Author and coordinate written responses to health authority questions and deficiency letters (with Regulatory Affairs).
- Plan/write/edit/review conference materials (abstracts, posters, oral presentations) and manuscripts.
- Coordinate and prioritize multiple deadlines; create/maintain project timelines.
- Perform quality review of documents to support the medical writing program.
Qualifications/Required & Preferred Skills:
- Bachelor’s degree required; MS/PhD/PharmD (or equivalent) preferred in Biology, Chemistry, Biochemistry, or related life sciences.
- 4+ years preparing clinical/regulatory documents; late-stage experience preferred.
- Strongly preferred: experience supporting cell therapy, gene therapy, or biologics programs.
- Demonstrated ability to author/edit clinical-regulatory documents with minimal supervision.
- Working knowledge of ICH/GCP; FDA and EMA expectations; editorial standards.
- Preferred: experience supporting health authority interactions (briefing documents and written agency responses).
- Strong analytical, written/editorial, and organizational skills; ability to manage multiple projects and competing deadlines; effective collaboration with internal/outsourced teams.
Benefits:
- Medical, Dental, and Vision; Group Life Insurance; Long Term Disability (LTD); 401(k) Retirement Plan; EAP; FSA; Paid Time Off (PTO); company paid holidays (including year-end holiday week).
- Bonus.ly recognition program.
Base Salary: $165,000–180,000 (varies by skills and experience).
The Sr. Manager, Medical Writing supports clinical development, regulatory submissions, and scientific communications across Artiva Biotherapeutics. Reporting to the Associate Director, Medical Writing, authors clinical and regulatory documents and collaborates cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Pharmacovigilance. No direct reports.
DUTIES/RESPONSIBILITIES:
- Author clinical and regulatory documents, including protocols/amendments, Investigator Brochures, lab manuals, annual reports (e.g., DSURs/IND annual reports), clinical study reports, and clinical sections of regulatory submissions (IMPDs, INDs, CTAs, and BLAs/MAAs as applicable).
- Write, edit, and collaborate to ensure scientific accuracy, internal consistency, and compliance.
- Manage documents and apply consistent formatting/style for dossier review.
- Use standards/best practices for review, completion, and approval; ensure adherence to applicable regulatory requirements.
- Develop/maintain medical writing standards (templates and style guides).
- Review/edit documents authored by functional area representatives.
- Author and coordinate written responses to health authority questions and deficiency letters (with Regulatory Affairs).
- Plan/write/edit/review conference materials (abstracts, posters, oral presentations) and manuscripts.
- Coordinate and prioritize multiple deadlines; create/maintain project timelines.
- Perform quality review of documents to support the medical writing program.
Qualifications/Required & Preferred Skills:
- Bachelor’s degree required; MS/PhD/PharmD (or equivalent) preferred in Biology, Chemistry, Biochemistry, or related life sciences.
- 4+ years preparing clinical/regulatory documents; late-stage experience preferred.
- Strongly preferred: experience supporting cell therapy, gene therapy, or biologics programs.
- Demonstrated ability to author/edit clinical-regulatory documents with minimal supervision.
- Working knowledge of ICH/GCP; FDA and EMA expectations; editorial standards.
- Preferred: experience supporting health authority interactions (briefing documents and written agency responses).
- Strong analytical, written/editorial, and organizational skills; ability to manage multiple projects and competing deadlines; effective collaboration with internal/outsourced teams.
Benefits:
- Medical, Dental, and Vision; Group Life Insurance; Long Term Disability (LTD); 401(k) Retirement Plan; EAP; FSA; Paid Time Off (PTO); company paid holidays (including year-end holiday week).
- Bonus.ly recognition program.
Base Salary: $165,000–180,000 (varies by skills and experience).