Director, Global Medical Writing — Regulatory Submissions Lead

Deciphera Pharmaceuticals Inc.; Waltham (MA); On-site; USD 175,000 - 215,000; Full time

Benefits offered by this job

Annual bonus

Benefits package (medical, dental, 401

Parental leave

Growth opportunities

Job summary

Deciphera Pharmaceuticals Inc. is seeking an experienced Director, Global Medical Writing to lead writers across programs and submissions in the growing clinical pipeline.

This high-visibility role requires independent authoring and management of protocols, IBs, and study reports, plus cross-functional leadership for NDA/MAA/IND submissions. You will mentor 1–2 direct reports, coordinate with CROs, keep the team current on regulatory expectations, and contribute to process improvements.

Qualifications

• MS or PhD in a scientific field.
• 8–10 years of medical writing experience.
• Expert knowledge in preparing high-quality clinical and regulatory documents.
• Experience with global submissions (NDA/MAA/IND) and regulatory timelines.

Responsibilities

• Lead medical writing for clinical programs and develop content strategies for regulatory documents.
• Represent Medical Writing on cross-functional teams and support NDA/IND submission planning.
• Author and manage clinical documents (protocols, IBs, CSR) within timelines and quality standards.
• Mentor 1–2 direct reports and coordinate work with CROs and in-house writers.
• Review deliverables and support exploratory analyses, tables, figures, and listings.

Skills

Medical writing leadership

Regulatory submissions

Cross-functional collaboration

Project management

Mentoring

Scientific writing

eCTD/eSubmissions

Education

MS or PhD in a scientific field

Tools

Veeva Vault

SharePoint

MS Office

Smart Sheet

Job description

Deciphera Pharmaceuticals Inc. is seeking an experienced Director, Global Medical Writing to lead writers across programs and submissions in the growing clinical pipeline.

This high-visibility role requires independent authoring and management of protocols, IBs, and study reports, plus cross-functional leadership for NDA/MAA/IND submissions. You will mentor 1–2 direct reports, coordinate with CROs, keep the team current on regulatory expectations, and contribute to process improvements.