Director, Regulatory & Scientific Writing

Solid Biosciences•Boston, MA

12h•Onsite

About The Position

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases. The company's mission is to improve the daily lives of patients living with devastating rare diseases. They are seeking a Director of Regulatory & Scientific Writing to lead all medical writing activities for key clinical deliverables, regulatory documents, and scientific communications. This role requires an advanced science degree, deep expertise in rare disease and gene therapy development, exceptional leadership skills, cross-functional collaboration, and the ability to manage and oversee contract vendors. The Director will be accountable for delivering high-quality, scientifically rigorous, and compelling documentation to support global development and registration programs, as well as global publication and scientific communication efforts. This role will report to the Vice President of Regulatory Strategy & Intelligence and will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA.

Requirements

Advanced scientific degree (PhD, PharmD, MD, or MS).
10+ years of medical writing experience, including leadership of major regulatory submissions.
Specific experience in gene therapy, rare disease, neuromuscular, or cardiac therapeutic areas.
Specific experience in rare pediatric therapeutic areas.
Strong cross‑functional leadership and communication skills.

Nice To Haves

Experience with AAV gene therapy programs.
Prior medical writing management experience in a high‑growth biotech environment.
Familiarity with electronic document management systems.

Responsibilities

Develop and execute medical writing strategy in alignment with Regulatory, Clinical, Nonclinical, and Communications teams to support development and clinical‑stage gene therapy programs in neuromuscular and cardiac indications.
Lead and drive development of document strategy and structure and build medical writing function.
Partner cross functionally to ensure alignment on timelines, deliverables, responsibilities, and communication strategy.
Lead the planning, writing, management and review of key regulatory and standard annual reporting documents, including IND/CTA submissions, orphan drug and RMAT/Breakthrough Therapy designation packages, clinical study protocols, Investigator’s Brochures, CSRs, briefing books, and BLA/MAA modules.
Ensure all documents meet global regulatory requirements, internal quality standards, and program objectives.
Manage the development of scientific publications, abstracts, posters, and presentations for the science and clinical groups including contribution to the publication strategy.
Ensure consistency of scientific messaging across regulatory, nonclinical, clinical, and external communications.
Provide guidance on data interpretation and communication of complex scientific and gene therapy concepts.
Balance individual medical writing responsibilities with oversight and management of external vendors and consultants to deliver key deliverables.
Assess and manage external medical writing vendor use.
Implement best practices, templates, and processes to enhance efficiency and document quality.
Ensure all documents comply with ICH, GCP, and global regulatory guidelines.
Establish and maintain document standards, style guides, and quality control processes including oversight of a QC vendor.
Drive continuous improvement initiatives.

Benefits

Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
401(k) program participation with competitive company matched contributions
Eligibility to participate in Solid’s Employee Stock Purchase Plan
Mobile phone subsidy for eligible employees
Tuition Reimbursement
Vision Coverage
Life Insurance
Voluntary Pet Insurance
Employee Discount Program on Travel, Entertainment, and Services
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)