Director, Regulatory & Scientific Writing

Job Description

Job Description

Director, Regulatory & Scientific Writing – Solid Biosciences

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.

Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.

We are seeking a Director of Regulatory & Scientific Writing, who will serve as the leader for all medical writing activities for key clinical deliverables (protocols, IBs, etc), regulatory documents (briefing books, agency questions, etc), and scientific communications (posters, presentations, abstracts). This role requires an advanced science degree and deep expertise in rare disease and gene therapy development, exceptional leadership skills, the ability to collaborate effectively cross functionally, 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.

Key Position Responsibilities

• Leadership of Medical Writing Function
  • 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.

• Global Regulatory & Clinical Documentation
  • 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.

• Scientific & Cross-Functional Communication
  • 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.

• Capacity & Vendor Management
  • 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.

• Quality, Compliance, & Process Excellence
  • 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.

Experience Requirements

• Required
  • 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.

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

• Key Position Attributes
  • Strategic thinker with strong execution skills
  • Collaborative, influential, and solutions-oriented
  • Comfortable operating in ambiguity and building processes from the ground up
  • Patient-focused mindset with a passion for rare disease innovation

Compensation

The base compensation range for this role is: $220,000 - $249,467
Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.

Benefits and Solid Advantages

At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.

• 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)