Director, Medical Writing

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🔥 1 minute ago

🇺🇸 United States – Remote

💵 $220.5k - $269.5k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Obsidian Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 Series C on 2024-04

Healthcare • Consulting • Manufacturing

Obsidian Therapeutics is a leading biotechnology company pioneering in the field of precision cell and gene therapy. Utilizing its proprietary cytoDRiVE® platform, the company engineers precision medicines by harnessing the power of regulated therapeutic proteins. Obsidian's innovative programs, including the OBX-115, target advanced melanoma and have been recognized by the FDA with both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations. Their pipeline of investigational therapies is designed to offer new hope for patients with unmet medical needs.

📋 Description

• Develop and execute the company’s medical writing strategy for clinical development, regulatory submissions, and launch readiness • Partner with Regulatory Affairs on strategic alignment, submission readiness, messaging consistency, and regulatory compliance • Translate complex clinical, statistical, safety, translational, and manufacturing information into clear scientific narratives • Lead authoring, review, and finalization of BLA documents, Module 2 clinical summaries, Clinical Study Protocols, Investigator Brochures, CSRs, SAP summaries, ISS, ISE, and responses to health authority questions • Collaborate with Clinical Development and Biometrics to construct evidence packages • Serve as primary medical writing representative on cross-functional program and submission teams • Drive alignment on scientific messaging, timelines, and review processes • Establish document planning, governance, standards, templates, and quality systems • Ensure consistency across protocols, SAPs, CSRs, safety documents, and regulatory summaries • Contribute to inspection readiness and document traceability • Establish efficient document development processes • Build a scalable medical writing operating model and oversee contract writers, editors, and publishing vendors • Identify risks, resource constraints, and submission-critical dependencies and implement mitigation plans • Implement best practices for content reuse, document standards, authoring technologies, and quality control • Develop and maintain writing templates, style guides, and document repositories • Ensure compliance with ICH, GCP, FDA, EMA, and company quality requirements

🎯 Requirements

• Advanced scientific degree preferred (PhD, PharmD, MD, or equivalent); Master's degree with significant relevant experience will be considered • 10+ years of biotechnology or pharmaceutical medical writing experience • Demonstrated experience authoring and leading major regulatory submission documents, including experience supporting BLA/NDA • Cell therapy experience highly preferred; oncology, gene therapy, or advanced therapeutics experience may be considered • Strong understanding of ICH guidelines and global regulatory requirements • Experience managing external medical writing vendors and consulting resources • Excellent scientific communication and project management skills • Ability to synthesize complex clinical and statistical information into clear, persuasive scientific narratives • Experience thriving in highly cross-functional small to mid-sized biotech environments • Strategic agility balancing long-term submission planning with near-term execution demands • Experience building and leading lean teams with strong external consultants • Ability to create and lead disciplined approaches that produce high-quality deliverables • Experience with ICH, GCP, FDA, and EMA requirements • Experience supporting BLA/NDA regulatory submissions

🏖️ Benefits

• Annual incentive bonus as a percentage of actual base salary • Long-term incentives in the form of employee stock options • Comprehensive medical, dental, and vision coverage • Company contributions to health savings and retirement accounts • Ample paid time off • Access to wellness programs • Rich career growth opportunities • Remote work arrangement