Job Description

Director/Senior Director, Medical Writing

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This range is provided by Braveheart Bio. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.

Base pay range

$216,000.00/yr - $296,000.00/yr

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About us:

Braveheart Bio is a Bay Areabased 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 role:

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. You will report to the Chief Development Officer and success in this role requires you to be adept at working cross-functionally with stakeholders.

Key responsibilities:

• 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
• Act as a key contributor to the organization cross-functionally to promote organizational goals and knowledge sharing

Required experience & skills:

• Bachelors 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 Masters (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
• Demonstrated ability to communicate and write clearly, concisely, and effectively; 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
• Ability to work collaboratively across cultures and geographies
• Proficient in Adobe Acrobat, and electronic document templates (e.g. eCTD templates)
• Collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and handson mindset with a rollupyoursleeves, cando attitude

Preferred experience & skills:

• If you can be onsite in San Francisco regularly, this is preferred, but we are open to remote/hybrid if needed
• Prior experience within the cardiovascular therapeutic area is highly desirable
• Direct experience leading the authoring and compilation of New Drug Applications (NDA) is highly desirable

We are an equal opportunity employer.

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.

Seniority level

• Director

Employment type

• Fulltime

Job function

• Writing/Editing and Science

Industries

• Biotechnology Research and Pharmaceutical Manufacturing

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