Senior Director, Medical Writing

GondolaBio

. 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 .

Posted 10/16/2026full-timeRemote • United StatesSenior💰 $270,000 - $280,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory medical writing expertise, including authoring clinical study protocols, reports, and regulatory submissions. Proficient in applying health authority regulations and ICH guidelines while managing multiple projects and ensuring submission readiness.

Highest-signal resume keywords

Regulatory Medical Writing ExperienceLead-Author ExperienceProficiency In Drug Development ProcessStrong Understanding Of Health Authority RegulationsProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ProtocolsClinical Study ReportsInvestigator BrochuresIND ApplicationsNDA/MAA SubmissionsRegulatory WritingData Disclosure KnowledgeQuality Control ChecksDocument Preparation ProcessesTFL Review

Soft Skills

Excellent Written Communication SkillsExcellent Oral Communication SkillsDetail-OrientedCollaborativeResponsive To Feedback

Industry Keywords

BiotechnologyPharmaceutical IndustryICH GuidelinesHealth Authority RegulationsClinical PharmacologyTranslational TeamsClinical Trial RegistrySubmission-Ready DocumentsDocument TimelinesReview Cycles

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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