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Director, Medical Writing
Obsidian Therapeutics. Develop and execute the company’s medical writing strategy for clinical development, regulatory submissions, and launch readiness .
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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