Senior Director, Medical Writing

Director/Senior Director, Medical Writing
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease.
Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation.
With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.
The Director/Senior Director, Medical Writing is responsible for the planning, coordination, and oversight of all medical writing activities within the company. In this role you will lead the Medical Writing function and be responsible for the development and implementation of a standardized process for the development of clinical and regulatory documents and will be responsible for managing external resources. Plan, manage, and author complex, strategic clinical and regulatory documents and submission packages
Oversee and/or author the development of critical documents, including Investigator Brochures, protocols/protocol amendments, and clinical study reports, in compliance with SOPs, ICH E3 guidelines, other applicable regulatory guidance documents, and local requirements
Select medical writing external resources, as needed
Develop the medical writing functional area, including creation of standardized policies, procedures, work instructions, timelines, document tools and templates, style guide, and best practices
Effectively engage and communicate with functional area leads and stakeholders across development programs to support medical writing activities
Provide leadership in planning and contributing to key regulatory submissions to US and global health authorities (NDAs, MAAs, INDs, annual reports, DSURs)
Ensure key messages are clear and consistent within and across documents
Contribute strategically and scientifically at the project and/or study team level
Forecast costs for individual medical writing projects
Generate and track medical writing project budgets against planned budget and timelines
Partner with legal and financial functions to negotiate medical writing contracts and budgets
Create and regularly update medical writing project timelines and ensure that medical writing timelines are in sync with the program timelines
Bachelor’s degree (life science preferred) combined with at least 10 years of pharmaceutical/biotechnology medical writing experience including development of regulatory documents for Phase 1-3 clinical trials
A Master’s (MS) or PhD degree may be considered in place of years of relevant experience
Subject matter expertise in the regulatory medical writing process with strong attention to detail
aptitude for compilation, analysis, and presentation of data
Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and other clinical and regulatory documents required for IND and NDA submissions
Demonstrated experience in a lead medical writing role managing projects of varying size and complexity, preferably within a pharmaceutical company or contract research organization (CRO)
Experience managing medical writing vendors and/or contract medical writers
Excellent communication skills to ensure that medical writing plans and processes are transparent, strict timelines are met, and risks, issues, and results are clear to all stakeholders
Outstanding organizational skills with the ability to multi-task, prioritize, negotiate, manage competing priorities, analyze and solve problems
Thorough knowledge of regulatory and compliance requirements for medical writing, including ICH E3 and other applicable guidelines
Fluency in English in both written and verbal communication skills
Proficient in Adobe Acrobat, and electronic document templates (e.g. eCTD templates)
Flexible, proactive, and hands‑on mindset with a roll‑up‑your‑sleeves, can‑do attitude
If you can be onsite in San Francisco regularly, this is preferred, but we are open to remote/hybrid if needed
Direct experience leading the authoring and compilation of New Drug Applications (NDA) is highly desirable
We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
Director

Full‑time

Writing/Editing and Science

Biotechnology Research and Pharmaceutical Manufacturing

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