Remote Director, Medical Writing

Summary

Join ML Bio Solutions as a Director, Medical Writing to deliver high-quality clinical and regulatory documents while working closely with Clinical Development, Clinical Operations, and Regulatory Affairs team members.

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

Responsibilities

• Participate in scientific communication planning, including development of strategic medical communication plans
• Provide medical & regulatory writing support and supervise medical writing activities, ensuring conformity to rigorous scientific standards, International Conference on Harmonization (ICH) and other relevant regulatory guidelines, to deliver quality documents according to the planned timeline
• 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 that reinforces the concept that staff at all levels are expected to assist others
• Promote efficiency, quality and consistency in internal processes, and assist in development and implementation of SOPs when appropriate

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve 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. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• 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