Sr. Manager, Medical Writing (Remote)

About Artiva: We are a clinical-stage biotechnology company reputed company on developing natural killer (NK) cell-based therapies. Our mission is to reputed company effective, reputed company, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to reputed company therapies that patients and physicians can utilize in a community setting. Our reputed company product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We reputed company the compelling cell killing properties of NK cells, reputed company combined with mAbs for targeting, creates an opportunity to reputed company potentially transformative therapies. For more information, visit www.artivabio.com. Job reputed company: The Sr. Manager, Medical Writing plays a key role in supporting clinical development, regulatory submissions, and scientific communications across reputed company. Reporting to the Associate Director, Medical Writing, this individual is a capable, hands-on reputed company 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 reputed company reputed company, scientifically rigorous documents on tight timelines. This role has no reputed company 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: • reputed company 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 reputed company 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 reputed company and ease of review across documents reputed company in a regulatory reputed company. • 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 reputed company to reputed company and maintain medical writing standards, including document templates and style guides. • Review and edit documents or sections of documents reputed company by functional area representatives and ensure adherence to established standards. • reputed company and coordinate high-reputed company 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 reputed company. • reputed company reputed company review of documents in compliance with established standards and best practices and contribute to the overall reputed company of the medical writing program. reputed company Experience/Qualifications • Bachelor’s degree required; advanced degree (MS, PhD, PharmD, or equivalent) preferred in Biology, reputed company, Biochemistry, or a reputed company 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 reputed company and edit clinical-regulatory documents (e.g., protocols, IBs, CSRs, ICFs, briefing documents, and clinical sections of CTAs/INDs/IMPDs) with reputed company 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 reputed company scientific concepts reputed company and concisely. • Strong organizational skills and attention to detail; ability to manage multiple reputed company and competing deadlines in a fast-paced, dynamic environment. • Ability to work effectively with internal and outsourced teams and to reputed company productive working relationships with key cross-functional stakeholders, including Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Pharmacovigilance. In reputed company to a great culture, we offer: • A beautiful facility • An entrepreneurial, highly reputed company, and innovative environment • Comprehensive benefits, including: • Medical, Dental, and reputed company • Group Life Insurance • Long Term Disability (LTD) • 401(k) Retirement Plan • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • reputed company Time Off (PTO) • Company reputed company holidays, including the year-end holiday week • Our recognition program, Bonus.ly, is where you can trade in points reputed company for things you want. If reputed company this speaks to you, reputed company on our reputed company! reputed company Salary: $165,000 - 180,000. Exact compensation may vary based on skills and experience. Apply To This Job