Senior Director, Medical Writing
About The Position
GondolaBio is seeking a seasoned regulatory medical writing leader to take clinical and regulatory documents from initial drafts through final, submission-ready versions. The role authors and leads key documents that advance programs, including protocols, investigator brochures, clinical study reports, IND applications, briefing documents, and submission modules. The successful candidate applies health authority guidance and public disclosure requirements with sound judgment, collaborates effectively with study teams, manages reviews and conflicting comments, and ensures that document messages are supported by the data. This person will own documents end to end in a small, fast-moving company and contribute to process improvement and vendor management as programs grow. The Senior Director will lead medical writing for clinical documents and regulatory submissions, work closely with clinical development, biostatistics, data management, clinical pharmacology, regulatory, and translational teams, and manage timelines and review cycles. Responsibilities also include vendor oversight, quality control, document standards and processes, and preparation of public disclosure materials. The role is remote in the United States.
Requirements
- Bachelor's degree in a life science.
- 10+ years of regulatory medical writing experience in the biotechnology or pharmaceutical industry.
- Lead-author experience on protocols, clinical study reports, and investigator brochures.
- Medical writing experience across multiple regulatory filings at various stages of development.
- Proficiency in the drug development process and a strong understanding of health authority regulations, ICH guidelines, and medical writing standards, with the ability to apply them to document writing.
- Excellent written and oral communication skills, including the ability to summarize complex scientific and clinical data concisely, accurately, and clearly.
- Strong project management skills, with the ability to work independently, manage multiple documents at once, and meet tight timelines.
- Collaborative, detail-oriented, and responsive to feedback.
Nice To Haves
- Advanced scientific or medical degree, such as an MS, MPH, PhD, or PharmD.
- Experience with EndNote, StartingPoint templates, and Veeva Vault.
- Rare disease and/or oligonucleotide (siRNA, ASO) program experience.
- Experience managing writing vendors or contractors.
- Prior experience in a small or fast-growing biotech environment.
- Curiosity and adaptability in adopting AI-enabled tools to improve clarity, speed, and quality of work.
Responsibilities
- Author and lead clinical study protocols and amendments, clinical study reports, investigator brochures, and related clinical study documents from concept to final product.
- Partner with clinical development, biostatistics, and data management on review of tables, figures, and listings (TFLs) and case narrative planning.
- Ensure results and key messages in clinical documents accurately reflect TFLs and other data sources.
- Prepare public disclosure documents, including clinical trial registry postings and results summaries.
- Provide oversight of vendors and contractors engaged for medical writing deliverables.
- Lead medical writing for regulatory submissions, including IND applications, health authority meeting requests and briefing documents, responses to health authority questions, and future NDA/MAA clinical modules and submission packages.
- Apply knowledge of regulatory writing and data disclosure requirements to submissions.
- Ensure documents follow internal processes, are submission-ready, and are appropriately archived in the document management system.
- Perform and coordinate quality control checks on medical writing deliverables and address findings.
- Suggest improvements to templates and document preparation processes.
- Serve as the Medical Writing point of contact for clinical, regulatory, biostatistics, clinical pharmacology, and translational teams.
- Project manage document timelines and review cycles, clarifying and addressing conflicting or ambiguous comments in a timely and efficient manner.
Benefits
- Patient Days to hear directly from individuals living with the conditions GondolaBio aims to impact.
- Access to learning and development resources.
- Robust and market-competitive compensation and benefits package, including base salary and health, welfare, and retirement programs.
- Flexible PTO.
- Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time.
- Partnerships with leading institutions.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
