Director, Regulatory & Scientific Writing
Solid Biosciences
June 25, 2026
On-site
Boston, MA
$220,000 - $249,467 USD yearly
Corporate Functions
Key Responsibilities:
- Lead the medical writing function; develop and execute a medical writing strategy aligned with Regulatory, Clinical, Nonclinical, and Communications.
- Drive document strategy/structure and build the medical writing function.
- Partner cross-functionally to align on timelines, deliverables, responsibilities, and communication strategy.
- Plan, write, manage, and review regulatory and standard annual reporting documents: IND/CTA submissions, orphan drug and RMAT/Breakthrough Therapy designation packages, clinical study protocols, Investigator’s Brochures, CSRs, briefing books, and BLA/MAA modules.
- Manage development of scientific publications, abstracts, posters, and presentations; contribute to publication strategy.
- Ensure consistent scientific messaging across regulatory, nonclinical, clinical, and external communications.
- Provide guidance on interpretation and communication of complex scientific/gene therapy concepts.
- Balance internal medical writing work with oversight of external vendors/consultants; assess and manage vendor use; implement templates and best practices.
- Ensure compliance with ICH and GCP; establish document standards/style guides and QC processes; oversee QC vendor; drive continuous improvement.
Qualifications (Required):
- Advanced scientific degree (PhD, PharmD, MD, or MS).
- 10+ years medical writing experience, including leadership of major regulatory submissions.
- Experience in gene therapy, rare disease, neuromuscular, or cardiac therapeutic areas.
- Experience in rare pediatric therapeutic areas.
- Strong cross-functional leadership and communication.
Qualifications (Preferred):
- Experience with AAV gene therapy programs.
- Medical writing management experience in a high-growth biotech environment.
- Familiarity with electronic document management systems.
Compensation/Benefits:
- Base compensation range: $220,000–$249,467.
- Eligible for short-term and long-term incentives (cash bonus and equity).
- Benefits include health/dental (FSA/HSA), 401(k) with match, Employee Stock Purchase Plan, tuition reimbursement, vision/life insurance, and onsite options (as listed).
- Lead the medical writing function; develop and execute a medical writing strategy aligned with Regulatory, Clinical, Nonclinical, and Communications.
- Drive document strategy/structure and build the medical writing function.
- Partner cross-functionally to align on timelines, deliverables, responsibilities, and communication strategy.
- Plan, write, manage, and review regulatory and standard annual reporting documents: IND/CTA submissions, orphan drug and RMAT/Breakthrough Therapy designation packages, clinical study protocols, Investigator’s Brochures, CSRs, briefing books, and BLA/MAA modules.
- Manage development of scientific publications, abstracts, posters, and presentations; contribute to publication strategy.
- Ensure consistent scientific messaging across regulatory, nonclinical, clinical, and external communications.
- Provide guidance on interpretation and communication of complex scientific/gene therapy concepts.
- Balance internal medical writing work with oversight of external vendors/consultants; assess and manage vendor use; implement templates and best practices.
- Ensure compliance with ICH and GCP; establish document standards/style guides and QC processes; oversee QC vendor; drive continuous improvement.
Qualifications (Required):
- Advanced scientific degree (PhD, PharmD, MD, or MS).
- 10+ years medical writing experience, including leadership of major regulatory submissions.
- Experience in gene therapy, rare disease, neuromuscular, or cardiac therapeutic areas.
- Experience in rare pediatric therapeutic areas.
- Strong cross-functional leadership and communication.
Qualifications (Preferred):
- Experience with AAV gene therapy programs.
- Medical writing management experience in a high-growth biotech environment.
- Familiarity with electronic document management systems.
Compensation/Benefits:
- Base compensation range: $220,000–$249,467.
- Eligible for short-term and long-term incentives (cash bonus and equity).
- Benefits include health/dental (FSA/HSA), 401(k) with match, Employee Stock Purchase Plan, tuition reimbursement, vision/life insurance, and onsite options (as listed).