Director, Medical Writing & Regulatory Strategy

BioSpace; United States; A distancia; USD 190.000 - 235.000; Jornada completa

Descripción de la vacante

Dyne Therapeutics is seeking a Director of Medical Writing to lead and execute high-quality clinical and regulatory documents for FDA submissions, collaborating across Clinical Development, Regulatory, and Medical Affairs. Based in Waltham, MA or remote.

The role drives planning, authoring, review, and finalization, ensuring messaging aligns with SOPs, ICH/GCP, and regulatory requirements, while building efficient processes.

Formación

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 10+ years in medical writing within pharma/biotech.
• Significant experience authoring and reviewing clinical/regulatory documents.
• Ability to lead strategic discussions and influence cross-functional stakeholders.
• Experience overseeing internal and external medical writing resources.
• Proficient in preparing protocols, CSR, Investigator brochures, CTD modules.
• Strong knowledge of FDA and international regulations, ICH, CTD requirements.
• Experience developing medical writing strategy across programs.
• Proficient with MS Office, Adobe Acrobat, SharePoint.
• Highly organized with the ability to manage multiple projects.
• Attention to detail and ability to present complex data clearly.
• Self-directed and proactive in fast-paced environments.
• Strong collaboration and input integration.

Responsabilidades

• Lead planning, authoring, review, and completion of clinical/regulatory documents for FDA and global health authorities.
• Manage internal and external medical writing resources to deliver high-quality documents on time.
• Author, edit, and collaborate with cross-functional team on protocols, investigator brochures, CSR, CTD modules, and submission materials.
• Review and refine documents to ensure quality, consistency, and regulatory compliance.
• Contribute to project planning and cross-functional groups to support submissions.
• Establish and improve medical writing processes, templates, and best practices.

Conocimientos

Medical writing

Regulatory documents

FDA regulations

ICH guidelines

CTD modules

Clinical study reports

Investigator brochures

Vendor management

Cross-functional leadership

Strategic communication

Project leadership

Document management

SharePoint

Microsoft Office

Adobe Acrobat

Attention to detail

Problem solving

Educación

Bachelor’s degree in life sciences

Herramientas

Microsoft Office

Adobe Acrobat

SharePoint

Descripción del empleo

Dyne Therapeutics is seeking a Director of Medical Writing to lead and execute high-quality clinical and regulatory documents for FDA submissions, collaborating across Clinical Development, Regulatory, and Medical Affairs. Based in Waltham, MA or remote.

The role drives planning, authoring, review, and finalization, ensuring messaging aligns with SOPs, ICH/GCP, and regulatory requirements, while building efficient processes.