Director/Senior Director, Medical Writing

San Francisco, CA /
Eidos – Regulatory Affairs /
Full-time
Eidos Therapeutics, a BridgeBio Pharma company, is a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.
 
BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.
 
To learn more, visit us at eidostx.com / https://bridgebio.com

Who You Are:

This experienced Medical Writer will lead medial writing activities associated with the planning, development and finalization of high-quality clinical and regulatory documentation. This individual is the responsible subject-matter expert in the field of medical writing and will function as an individual contributor while providing oversight of contract medical writers. The successful candidate is expected to develop strong relationships with various departments and with different levels of management, including interactions across BridgeBio subsidiaries. The scope ranges from early clinical development through submission and maintenance of license applications.

Requirements:

    • Lead medical writing process for new protocols/synopses, protocol amendments, clinical study reports, investigator brochures, and related regulatory documents
    • Align cross-functionally to set strategies and goals for the management of internal and external medical writing resources to meet corporate goals and team objectives
    • Ensure company templates and medical writing deliverables conform with regulatory requirements (eg, International Conference on Harmonization (ICH) and other relevant regulatory guidelines)
    • Maintain a company style guide that includes standard language for regulatory documents
    • Partner with clinical development, biostatistics and data management in the review and development of tables, figures, and listings (TFLs), and for case narrative planning
    • Work closely with study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
    • Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
    • Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately archived in agreed document management system
    • Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements
    • Suggest or identify modifications and improvements to document preparation processes and company templates in order to improve quality, efficiency, and productivity

Education, Experience & Skills Requirements:

    • At least a Bachelor of Science or equivalent degree, post-graduate degree preferred
    • Successful experience leading medical writing activities for multiple regulatory filings at various development stages
    • Excellent oral and written communication skills with an ability to summarize complex raw data in a concise, accurate and easily understandable form
    • Thorough knowledge of clinical research, health authority regulations, ICH Guidelines and medical writing standards with ability to interpret and apply these to document writing
    • Excellent interpersonal, active listening, and influencing skills
    • Strong leadership and project management skills, ability to work independently, multi-task, and work effectively under pressure
    • Prior management experience preferred

What We Offer:

    • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
    • Learning and development training to help employees be the best version of themselves
    • Collaborative business environment
    • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
    • Excellent benefits package
    • Flexible PTO
    • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
    • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
    • Work with the most productive groups of R&D operators in the industry
    • Partnerships with leading institutions
    • A platform for meaningful scientific contributions to shine
    • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so