Backed by GV.
About the role
We’re looking for a highly motivated Director, Medical Writing with BLA/NDA experience to lead the strategic planning, development, and execution of regulatory and clinical documents supporting the advancement of Obsidian’s clinical development programs.
What they're looking for
- 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
More about this role
About Us …
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.
We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
We’re looking for a highly motivated Director, Medical Writing with BLA/NDA experience to lead the strategic planning, development, and execution of regulatory and clinical documents supporting the advancement of Obsidian’s clinical development...
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