BridgeBio · 3 months ago
Executive Director, Medical Writing
San Francisco, CA/Hybrid
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$260K/yr - $300K/yr
10+ years expBridgeBio is a pioneering biopharmaceutical company focused on developing life-changing medicines for patients with unmet needs. The Executive Director of Medical Writing will establish and manage the Medical Writing group for the Cardiorenal affiliates, overseeing the development of clinical and regulatory documents while providing strategic leadership to study teams.
BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
Responsibilities
Oversee the Cardiorenal Medical Writing group, including leading, training, and mentoring for effective performance
Lead medical writing (including coordination of other Medical Writers) from concept to final product for clinical study protocols and associated forms, protocol amendments, clinical study reports, investigator brochures, and related clinical study documents
Provide strategic leadership to study teams to direct the preparation of protocols and CSRs, submissions, and other regulatory documents, and associated public disclosure documents
Lead medical writing (including coordination of other Medical Writers) from concept to final product for regulatory submissions including IND applications, health agency interaction Meeting Requests, Briefing Documents, , and related submissions, NDA/MAA data modules and overall submission packages, and other related documentation for initial and/or supplemental applications for marketing authorization or label expansion
Demonstrate in-depth knowledge of regulatory writing and data disclosure requirements
Ensure company SOPs related to document development, templates, and medical writing deliverables conform with regulatory requirements (eg, International Conference on Harmonization (ICH) and other relevant regulatory guidelines). Take ownership of processes related to documents and guide teams through these processes
Partner with clinical development, biostatistics, and data management in the review and development of tables, figures, and listings (TFLs), and for case narrative planning
Work closely with study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other data sources
Project manage the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed in a timely and efficient manner
Ensure documents are generated in accordance with agreed internal processes and standards, are submission-ready, and are appropriately archived in the agreed document management system
Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements
Establish Medical Writing support models and implement strategies to improve operational efficiencies. Suggest or identify modifications and improvements to document preparation processes and company templates to continuously improve quality, efficiency, and productivity. Apply relevant experience in process initiative and/or vendor management
Qualification
Required
Post-graduate scientific or medical degree (eg, MS, MPH, PhD, PharmD, MD, DO) with 10+ years of experience as a regulatory medical writer within the biotechnology or pharmaceutical industry
Experienced in medical writing activities for multiple regulatory filings at various development stages
Experience managing consultants and their projects
Excellent oral and written communication skills, with the ability to summarize and present complex scientific and clinical data effectively with concise, accurate, and clear narrative flow and syntax
Proficient in the drug development process, and strong understanding of health authority regulations, ICH guidelines, and medical writing standards, with the ability to interpret and apply these to document writing
Excellent interpersonal, active listening, and influencing skills
Strong project management skills, ability to work independently, multi-task, and work effectively under pressure
Preferred
Experience with EndNote, StartingPoint templates, and Veeva Vault
Benefits
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
Company
BridgeBio
BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.
201-500 employees
H1B Sponsorship
BridgeBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$4.9BKey Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2026-01-16Debt Financing· $550M
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
BioWorld Financial Watch
2026-01-17
Company data provided by crunchbase