Global Medical Writing Director: Strategy & Submissions

Regulatory Jobs; United States; Remote; USD 175.000 - 215.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Benefits package

Parental leave

Growth opportunities

Zusammenfassung

Deciphera is seeking an experienced Director, Global Medical Writing to lead the writer program across clinical programs and regulatory submissions. The role requires independent writing and management of study documents such as protocols, master protocols, Investigator's brochures, and clinical study reports.

Reporting to the Senior Director, Global Medical Writing, you will guide cross-functional teams, maintain up-to-date industry knowledge, mentor 1–2 writers, and drive process improvements

Qualifikationen

• Advanced degree (MS or Ph.D.) in a relevant scientific field.
• Ph.D. degree is preferred.
• Minimum of 8-10 years medical writing experience.
• Expert knowledge of and experience in preparing high quality clinical and regulatory documents.
• Knowledge of clinical trial disclosure.

Aufgaben

• Lead medical writing for one or more clinical programs, planning, development, and implementation of content strategy for regulatory documents.
• Represent Medical Writing on cross-functional teams and participate in NDA/MAA/IND submission planning.
• Author and manage clinical documents within timelines with high quality in terms of scientific content, organization, and accuracy.
• Drive document strategies with subject matter experts and stakeholders.
• Coordinate work with in-house writers and outside CROs.
• Mentor 1–2 direct reports and oversee writing across a therapeutic area.
• Review deliverables and regulatory documents; ensure consistency and compliance.

Kenntnisse

Medical writing leadership

Regulatory writing

Cross-functional collaboration

Regulatory submission planning

Communication skills

Ausbildung

MS or PhD in a scientific field

Tools

eCTD starting point

Veeva Vault

Please Review

Smart Sheet

MS Office Suite

SharePoint

Jobbeschreibung

Deciphera is seeking an experienced Director, Global Medical Writing to lead the writer program across clinical programs and regulatory submissions. The role requires independent writing and management of study documents such as protocols, master protocols, Investigator's brochures, and clinical study reports.

Reporting to the Senior Director, Global Medical Writing, you will guide cross-functional teams, maintain up-to-date industry knowledge, mentor 1–2 writers, and drive process improvements