Director, Medical Writing

BBOT

Director of Medical Writing responsible for strategic leadership and document delivery at BridgeBio Oncology Therapeutics. Leading complex regulatory submissions with a focus on oncology therapeutics.

Posted 7/17/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Medical Writing, including the development of clinical and regulatory documents, while leading teams and managing resources effectively in a biopharmaceutical context. Proficient in navigating global regulatory requirements and fostering collaboration across cross-functional teams.

Highest-signal resume keywords

Medical Writing LeadershipRegulatory Submissions ExpertiseTeam ManagementGlobal Regulatory KnowledgeStrategic Planning

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical WritingClinical Trial Document LifecycleRegulatory Document DevelopmentProject LeadershipResource ManagementQuality Process EstablishmentClinical Study ReportsProtocolsInvestigator's BrochuresCTD Summaries

Soft Skills

Strategic ThinkingOrganizational SkillsInfluential CommunicationCollaborationLeadership

Tools & Technologies

Microsoft OfficeAdobe AcrobatSharePointVeeva RIMEndNote

Certifications & Qualifications

Bachelor's Degree in Life SciencesAdvanced Degree (PhD, PharmD, MD, or Master's Degree) Preferred

Industry Keywords

Biopharmaceutical IndustryFDAEMAICHGCPINDsNDAsBLAsMAAsMedical Writing Standards

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provides strategic and operational leadership for the Medical Writing function.
Responsible for planning, development, and delivery of high-quality clinical and regulatory documents.
Serves as a strategic partner to Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional leaders.
Responsible for establishing medical writing standards, building organizational capabilities, and ensuring portfolio-wide execution of medical writing activities.
Develops and executes the Medical Writing functional strategy aligned with corporate and development objectives.
Manages Medical Writing resource plans, including internal staffing, contractor oversight, and vendor management strategies.
Establishes and maintains Medical Writing governance, standards, templates, and quality processes.

Requirements

What you’ll need

Bachelor's degree in Life Sciences or related discipline required; advanced degree (PhD, PharmD, MD, or Master's degree) preferred.
Minimum of 12 years of experience in the biopharmaceutical industry, including at least 10 years of progressive medical writing experience.
Minimum of 3 years of people leadership or functional management experience.
Demonstrated success leading Medical Writing activities for complex global regulatory submissions, including INDs, NDAs, BLAs, and MAAs.
Deep expertise across the clinical trial document lifecycle, including protocols, Investigator's Brochures, Clinical Study Reports, CTD summaries, and health authority briefing documents.
Extensive knowledge of global regulatory requirements and guidelines, including FDA, EMA, ICH, and GCP.
Proven experience building and managing medical writing teams, contractors, and external vendors.
Demonstrated ability to independently lead in a fast-paced, dynamic, and highly collaborative biotechnology environment.
Strong strategic thinking, organizational, and project leadership skills.
Excellent written and verbal communication skills and the ability to influence at all levels of the organization.
Proficiency with standard business applications and industry systems, including Microsoft Office, Adobe Acrobat, SharePoint, Veeva RIM, EndNote, and related document management platforms.

Benefits

Comp & perks

comprehensive health benefits
annual performance bonus
company equity