Senior Manager, Medical Writing

🔥 2 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $165k - $180k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

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Artiva Biotherapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 Series B on 2021-02

Biotechnology • Healthcare • Pharmaceuticals

Artiva Biotherapeutics is an immunotherapy company dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit. The company specializes in producing off-the-shelf, allogeneic NK cell therapies at a massive scale. Its mission focuses on developing effective, safe, and accessible therapies for patients suffering from autoimmune diseases and cancers. Notably, their lead program, AlloNK®, is a non-genetically modified NK cell therapy candidate currently undergoing clinical trials for treatments of systemic lupus erythematosus and Non-Hodgkin Lymphoma, among others.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.