Regulatory Medical Writing Director

Regulatory Jobs; Redwood City (CA); Sur place; USD 184 000 - 243 000; Plein temps

Résumé du poste

Corcept Therapeutics Corporation in Redwood City seeks a Director-level Regulatory Medical Writer to lead medical writing efforts supporting US and ex-US regulatory submissions. You will manage in-house writers and vendors, ensure alignment with NDAs, CSRs, and IND/NDA content, and guide content, format, and style.

Ideal candidates have 10+ years in regulatory medical writing, a BS in science with advanced degree preferred, strong leadership, and deep knowledge of eCTD, US/EU guidelines, and

Qualifications

• BA/BS degree in a scientific field; advanced degree preferred.
• 10+ years of regulatory medical writing at director level with team management.
• Experience drafting NDAs, protocols, CSRs, IBs, IND submissions and NDAs.
• Strong knowledge of US/EU regulatory guidelines and eCTD format.

Responsabilités

• Provide medical writing leadership in strategic project teams as the medical writing subject matter expert.
• Manage in-house writers, vendors and contractors with prioritization and timelines.
• Mentor and support direct reports in their skills and careers.
• Author, co-author, edit, and format regulatory documents (NDAs, protocols, CSRs, IBs).
• Collaborate with authors and reviewers to ensure timely, compliant deliverables.
• Develop and refine medical writing processes, templates, SOPs and QA controls.
• Maintain subject matter expertise on investigational products and regulatory guidelines.

Connaissances

Medical Writing Leadership

Regulatory Writing

Cross-Functional Collaboration

Attention to Detail

Communication Skills

eCTD Knowledge

MS Office

Formation

BA/BS in science

Advanced degree preferred (PhD/PharmD/MS)

Outils

Veeva Vault

Box

SharePoint

Adobe Acrobat

MS Office (Word/Excel/PowerPoint)

Description du poste

Corcept Therapeutics Corporation in Redwood City seeks a Director-level Regulatory Medical Writer to lead medical writing efforts supporting US and ex-US regulatory submissions. You will manage in-house writers and vendors, ensure alignment with NDAs, CSRs, and IND/NDA content, and guide content, format, and style.

Ideal candidates have 10+ years in regulatory medical writing, a BS in science with advanced degree preferred, strong leadership, and deep knowledge of eCTD, US/EU guidelines, and