Senior Director, Medical Writing

GondolaBio Service Co • Palo Alto, CA

1d • Remote

About The Position

GondolaBio is seeking a seasoned regulatory medical writing leader to own clinical and regulatory documents from first draft through final, submission-ready versions. The role leads writing across clinical and regulatory documents, 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, works closely with study teams to interpret complex data, manages review processes, and ensures document messages are supported by the data. In a small, fast-moving company, this person will own documents end to end while supporting process improvement and vendor management as programs grow.

The Senior Director serves as the medical writing point of contact for clinical, regulatory, biostatistics, clinical pharmacology, and translational teams. The role oversees document quality, timelines, review cycles, quality control, and archiving, and leads medical writing for regulatory submissions at multiple stages of development. This is a remote position in the United States.

Requirements

• Bachelor's degree in a life science.
• 10 or more 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, including the ability to work independently, manage multiple documents simultaneously, 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, amendments, clinical study reports, investigator brochures, and related clinical study documents from concept to final product.
• Partner with clinical development, biostatistics, and data management teams to review tables, figures, and listings (TFLs) and plan case narratives.
• 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.
• Oversee vendors and contractors engaged for medical writing deliverables.
• Lead medical writing for IND applications, health authority meeting requests and briefing documents, responses to health authority questions, and future NDA/MAA clinical modules and submission packages.
• Apply 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 efficiently.

Benefits

• Patient Days to hear from individuals living with the conditions the company seeks to impact.
• Learning and development resources.
• Robust and market-competitive compensation and benefits package, including base salary, health, welfare, and retirement programs.
• Flexible PTO.
• Potential to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time.
• Partnerships with leading institutions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior