Director, Medical Writing

5 days ago

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Description

• Responsible for delivering high-quality clinical and regulatory documents such as briefing documents, protocols, investigator brochures, CSRs, as well as NDA/MAA documents • Work closely with Clinical Development, Clinical Operations, and Regulatory Affairs team members, as well as other internal team members and external collaborations • Participate in scientific communication planning, including development of strategic medical communication plans • Provide medical & regulatory writing support and supervise medical writing activities • Facilitate the development of project timelines, document content, team review, and comment resolutions discussions across the team • Develop and maintain a company style guide that includes standard language for regulatory documents • Perform literature searches/reviews as necessary to obtain background information and training for document development • Effectively manage external medical writing resources, and in future, internal medical writing resources • Facilitate open, clear communication and collaborate in a mutually supportive and cooperative manner • Promote efficiency, quality and consistency in internal processes, and assist in development and implementation of SOPs when appropriate

Requirements

• Excellent oral and written communication skills with an ability to summarize complex raw data in a concise, accurate and easily understandable form • Excellent understanding of clinical development and industry regulatory requirements, including knowledge of FDA and ICH requirements for clinical activities • Excellent interpersonal and influencing skills to establish and maintain professional and productive working relationships with team members • Ability to communicate with teams to set realistic timeline expectations as well as demonstrated ability to deliver according to agreed timelines • Ability to work independently with minimal supervision, adept at managing multiple competing priorities and aggressive timelines, with close attention to detail, and demonstrated initiative and professional integrity • 8-12 years of medical writing experience in the pharmaceutical industry • Broad experience managing the medical writing responsibilities associated with multiple studies at various clinical development stages • At least a Bachelor of Science or equivalent degree • Evidence of being a critical strategic thinker who is solution-oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs. • Ability to prioritize multiple urgent priorities • Experience with eCTD submission requirements. • Travel – approximately 10-15%, remote

Benefits

• Patient Days, where we hear directly from individuals living with conditions impacting our efforts • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak • An unyielding commitment to always putting patients first. Learn more about how we do this here • A de-centralized model that enables our program teams to focus on advancing science and helping patients • A place where you own the vision – both for your program and your own career path • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game • Access to learning and development resources to help you get in the best professional shape of your life • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) • Flexible PTO • Rapid career advancement for strong performers • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time • Partnerships with leading institutions • Commitment to Diversity, Equity & Inclusion