Director, Medical Writing
New
O
Obsidian TherapeuticsBiotechnology, Pharmaceuticals
This is a remote roleFull-TimeDirector
Salary$220,500 — $269,500 USD
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Job Details
- Experience
- 10+ years
- Required Skills
- Project Management
Requirements
- Advanced scientific degree (PhD, PharmD, MD) preferred; Master's degree with significant experience considered.
- 10+ years of biotechnology or pharmaceutical medical writing experience.
- Demonstrated experience authoring and leading major regulatory submission documents, including BLA/NDA.
- Strong understanding of ICH guidelines and global regulatory requirements.
- Experience managing external medical writing vendors and consulting resources.
- Cell therapy experience highly preferred; oncology or gene therapy experience considered.
- Excellent project management skills with the ability to manage multiple complex tasks in parallel.
- Ability to synthesize complex clinical and statistical information into clear scientific narratives.
- Proven experience building and leading lean teams with external consultants.
- Strong communication skills with experience building buy-in across teams and senior leadership.
Responsibilities
- Develop and execute medical writing strategy for clinical development, regulatory submissions, and launch readiness.
- Partner with Regulatory Affairs to ensure strategic alignment, submission readiness, and compliance.
- Author and finalize major regulatory documents, including BLA/NDA, CSRs, protocols, and safety/efficacy summaries.
- Collaborate with Clinical Development and Biometrics to construct compelling evidence packages.
- Serve as the primary medical writing representative on cross-functional program and submission teams.
- Establish document planning, governance, standards, templates, and quality systems.
- Build a scalable medical writing operating model and manage external partners, contract writers, and publishing vendors.
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