Job Summary:
The Sr. Manager, Medical Writing plays a key role in supporting clinical development, regulatory submissions, and scientific communications across Artiva Biotherapeutics. Reporting to the Associate Director, Medical Writing, this individual is a capable, hands-on author of clinical and regulatory documents and a reliable contributor across cross-functional teams. The ideal candidate brings practical experience leading and preparing clinical and regulatory documents, a working knowledge of ICH/GCP and global regulatory expectations, and the ability to deliver clear, scientifically rigorous documents on tight timelines. This role has no direct reports and helps ensure that medical writing deliverables meet the highest scientific, editorial, and compliance standards through cross-functional collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Pharmacovigilance.
DUTIES/RESPONSIBILITIES:
- Author clinical and regulatory documents, including clinical study protocols and 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 with members of the clinical development team on a variety of clinical and regulatory documents, ensuring scientific accuracy, internal consistency, and compliance with established standards.
- Support efficient document management and apply a consistent style of presentation to maintain quality and ease of review across documents assembled in a regulatory dossier.
- Apply established standards and best practices for the document review, completion, and approval process; ensure adherence to regulatory requirements and guidelines, where applicable.
- Collaborate with the team to develop and maintain medical writing standards, including document templates and style guides.
- Review and edit documents or sections of documents prepared by functional area representatives and ensure adherence to established standards.
- Author and coordinate high-quality written responses to health authority questions and deficiency letters in collaboration with Regulatory Affairs and other cross-functional partners.
- Plan, write, edit, and review materials in collaboration with project teams, including conference abstracts, posters, oral presentations, and manuscripts, ensuring alignment with scientific strategies and corporate goals.
- Coordinate and prioritize multiple project deadlines in a fast-paced environment; create and maintain timelines for assigned projects.
- Perform quality review of documents in compliance with established standards and best practices and contribute to the overall quality of the medical writing program.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
- Bachelor's degree required; advanced degree (MS, PhD, PharmD, or equivalent) preferred in Biology, Chemistry, Biochemistry, or a related life science discipline.
- Four or more years' experience preparing clinical and regulatory documents in a life science organization, including late-stage development experience (e.g., CSRs, BLA/MAA clinical sections).
- Experience supporting cell therapy, gene therapy, or biologics programs is strongly preferred.
- Demonstrated ability to author and edit clinical-regulatory documents (e.g., protocols, IBs, CSRs, ICFs, briefing documents, and clinical sections of CTAs/INDs/IMPDs) with minimal supervision.
- Working knowledge of ICH/GCP guidelines, FDA and EMA expectations for clinical-regulatory documents, and applicable editorial standards.
- Experience supporting health authority interactions, including preparation of briefing documents and written responses to agency questions, is preferred.
- Strong analytical, written, and editorial skills; ability to communicate complex scientific concepts clearly and concisely.
- Strong organizational skills and attention to detail; ability to manage multiple projects and competing deadlines in a fast-paced, dynamic environment.
- Ability to work effectively with internal and outsourced teams and to develop productive working relationships with key cross-functional stakeholders, including Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Pharmacovigilance.
In addition to a great culture, we offer:
- A beautiful facility
- An entrepreneurial, highly collaborative, and innovative environment
- Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
Base Salary: $165,000 - 180,000. Exact compensation may vary based on skills and experience.
