Senior Director, Medical Writing

Job not on LinkedIn

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $270k - $280k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

GondolaBio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $300M Venture Round - GondolaBio on 2024-08

Healthcare • Consulting • Manufacturing

GondolaBio is a clinical-stage biopharmaceutical company launched in 2024 and affiliated with BridgeBio Pharma, focused on developing breakthrough therapeutics for patients with genetic diseases. The company uses a lean, decentralized approach to accelerate early-stage research and development across multiple modalities (including small molecules and oligonucleotide therapies) and is building a diverse pipeline targeting rare and underserved genetic conditions such as EPP/XLP with its lead program PORT-77. GondolaBio centers patient needs and aims to bring disease-modifying treatments more quickly to populations lacking approved therapies.

📋 Description

• Author and lead development of 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 TFL review and case narrative planning • Ensure results and key messages accurately reflect TFLs and other data sources • Prepare public disclosure documents, including clinical trial registry postings and results summaries • Oversee medical writing vendors and contractors • 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 knowledge to submissions • Ensure documents follow internal processes, are submission-ready, and are archived appropriately • Perform and coordinate quality control checks and address findings • Improve templates and document preparation processes • Serve as 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

🎯 Requirements

• Bachelor's degree in a life science required • 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 • Strong understanding of health authority regulations, ICH guidelines, and medical writing standards • Ability to apply regulations, guidelines, and standards to document writing • Excellent written and oral communication skills • Ability to summarize complex scientific and clinical data concisely, accurately, and clearly • Strong project management skills • Ability to work independently, manage multiple documents simultaneously, and meet tight timelines • Collaborative, detail-oriented, and responsive to feedback

🏖️ Benefits

• Patient Days • A culture inspired by values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak • De-centralized model enabling program teams to focus on advancing science and helping patients • Ownership of program vision and career path • Collaborative, fast-paced, data-driven environment • Access to learning and development resources • Robust and market-competitive compensation and benefits package • Health, welfare, and retirement programs • 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