Associate Director, Medical Writing

Job Description:

Associate Director, Medical Writing

The Associate Director, Medical Writing is responsible for providing medical writing leadership to deliver clinical/regulatory documents such as clinical study reports (CSRs), clinical protocols, and investigator brochures. This position works closely with internal clinical development functional leads and other team members, senior/executive leadership, and external collaborators. The scope of documents generally ranges from pre-IND through NDA.

Responsibilities

• Lead the development of clinical/regulatory documents and other assigned tasks within established timelines with minimal supervision.
• Maintain high document quality and appropriate standards for scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
• Review, edit, and ensure the quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives (as required), are consistent with QED and industry standards, ICH/GCP guidance, and all applicable regulatory requirements.
• Serve as a point of contact and initial oversight of vendors, escalating issues to management as necessary.
• Represent Medical Writing on one or more programs.
• Participate in the development and implementation of process improvements and/or standards within the Medical Writing function.
• Provide support for health authority transparency requirements (CTR, CSR results postings).
• Assist with the development and implementation of SOPs.
• Perform other duties as requested.

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

• Ability to lead Medical Writing efforts across the organization and to develop and mentor others.
• Excellent oral and written communication skills with an ability to summarize complex raw data in a concise, accurate, and easily understandable form.
• Close attention to detail and a demonstrated concern for standards.
• Strong project management and time management skills, along with initiative and ability to be productive with minimal supervision.
• Ability to exercise discretion and show good judgment, demonstrate honesty and integrity, and foster and encourage trust-building behaviors.
• Adaptable and flexible with excellent facilitation and team playing skills.
• Knowledge of IND/NDA/BLA/MAA submission requirements and familiarity with the eCTD structure.
• Excellent understanding of clinical development and industry regulatory requirements (ICH/FDA, GCP).
• Strong technological abilities, with proficiency in Microsoft Word, Excel, and PowerPoint. Strong command of routinely used business software/platforms (eg, Microsoft Office, Microsoft SharePoint, Adobe Acrobat, Veeva RIM, EndNote) is required.
• Minimum of 5 years as a medical writer in the pharmaceutical industry, including two years of management or de facto management level experience, or clear management potential.

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.