Director of Regulatory Writing — Lead Submissions & Strategy

Entrada-Therapeutics; Boston (MA); Sur place; USD 220 000 - 250 000; Plein temps

Avantages offerts par ce poste

Health, dental, vision

401(k) match

Parental leave

Education reimbursement

Discretionary time off

Commuting benefits

Résumé du poste

Entrada Therapeutics in Boston seeks a Director of Regulatory Writing to orchestrate high-quality regulatory documentation from preclinical through clinical and registration stages. You will lead authorship, coordinate internal and external resources, and drive process improvements in a fast-paced, mission-driven environment.

The role requires a track record in medical writing within pharma/biotech/CRO, strong collaboration across teams, and expertise in ICH, GCP, and FDA standards.

Qualifications

• BS or MS with at least 7 years of regulatory/medical writing.
• Strong work ethic and excellent communication; ability to collaborate with matrixed teams.
• Experience with medical writing in pharma/biotech/CRO.
• Expertise with Word and eCTD formatting.
• Understanding of ICH, GCP, and FDA standards governing regulatory docs.
• Experience in rare diseases, pediatrics, or Duchenne is a plus.

Responsabilités

• Lead planning and authoring of regulatory submission components from preclinical through NDA.
• Coordinate with external writers and internal contributors; manage communication.
• Serve as lead author and document expert for high-quality deliverables.
• Represent Regulatory Writing on cross-functional teams with Regulatory Affairs and PM.
• Improve SOPs, authoring guides, and project-management tools.
• Support submission-related activities with Regulatory Affairs.

Connaissances

Regulatory writing

Medical writing

Communication skills

Project coordination

Formation

BS/MS in scientific field

Outils

Microsoft Word

eCTD formatting

Description du poste

Entrada Therapeutics in Boston seeks a Director of Regulatory Writing to orchestrate high-quality regulatory documentation from preclinical through clinical and registration stages. You will lead authorship, coordinate internal and external resources, and drive process improvements in a fast-paced, mission-driven environment.

The role requires a track record in medical writing within pharma/biotech/CRO, strong collaboration across teams, and expertise in ICH, GCP, and FDA standards.