[Hiring] Senior Director, Medical Writing @GONDOLABIO SERVICECO INC

Role Description

Senior Director, Medical Writing

Location: Remote, US

You are a seasoned regulatory medical writing leader who takes clinical and regulatory documents from first draft to final, submission-ready version. You have authored and led the preparation of key documents that move programs forward:

• Protocols
• Investigator brochures
• Clinical study reports
• IND applications
• Briefing documents
• Submission modules

You know health authority guidance and public disclosure requirements well enough to apply them with judgment, not just by checklist. You work well with study teams, keep reviews moving, resolve conflicting comments, and ensure every message in a document is supported by the data. You are comfortable owning your documents end to end in a small, fast-moving company, and you are ready to take on more as our programs grow. You influence without authority, bring clarity to complex data, and see process improvement and vendor management as core parts of the job.

Qualifications

• Led medical writing from concept to final product for clinical and regulatory documents across multiple development stages, including IND/CTA components
• Authored clinical documents such as protocols, amendments, investigator brochures, and clinical study reports as the lead writer
• Worked closely with clinical development, biostatistics, and data management to interpret tables, figures, and listings (TFLs)
• Managed document timelines and review cycles across cross-functional teams
• Managed external medical writing vendors and consultants to deliver high-quality, submission-ready documents on time
• Owned document standards, templates, SOPs, and QC processes aligned with ICH and relevant regulatory guidelines

Requirements

• Bachelor's degree in a life science required; advanced scientific or medical degree (e.g., MS, MPH, PhD, PharmD) strongly preferred
• 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 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, with the ability to summarize complex scientific and clinical data concisely, accurately, and clearly
• Strong project management skills; able to work independently, manage multiple documents at once, and meet tight timelines
• Collaborative, detail-oriented, and responsive to feedback

Benefits

• Patient Days, where we hear directly from individuals living with the conditions we are seeking to impact throughout the year
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first
• A de-centralized model that enables our program teams to focus on advancing science and helping patients
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment
• Access to learning and development resources
• Robust and market-competitive compensation & benefits package
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion