Director, Medical Writing

About MLBio Solutions & BridgeBio Pharma

ML Bio Solutions (ML Bio), a BridgeBio company, is a biotechnology company founded in 2018, yet the company’s founders have been dedicated to finding a cure for Limb girdle muscular dystrophy type 2I/R9 FKRP-related (LGMD2I/LGMDR9) for close to twenty years. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas, including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.  
 
Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 
 
To learn more about our story and company culture, visit us at https://mlbiosolutions.com/ | https://bridgebio.com

Who You Are

ML Bio Solutions is searching for a Director, Medical Writing who will be responsible for delivering high-quality clinical and regulatory documents such as briefing documents, protocols, investigator brochures, CSRs, as well as NDA/MAA documents (strong preference for candidates who have previous IND/NDA/MAA document authoring experience).  This individual will work closely with Clinical Development, Clinical Operations, and Regulatory Affairs team members, as well as other internal team members and external collaborations.

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

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills 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

What We Offer

• 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