Medical Writing Director, Regulatory Submissions

Regulatory Jobs; Redwood City (CA); On-site; USD 190,000 - 223,000; Full time

Job summary

Corcept seeks a skilled medical writer to author and edit regulatory documents, including NDAs, protocols, and CSRs, ensuring accuracy and regulatory compliance. You will collaborate with Biometrics, Clinical Operations, and Regulatory Affairs to gather input and lead timelines for on-time submissions.

The role requires a strong background in regulatory medical writing, experience with US/European guidelines, and the ability to lead multiple projects with minimal supervision in a fast-paced

Qualifications

• BA/BS in a scientific field required; advanced degree preferred.
• 7+ years of regulatory medical writing experience in pharma.
• Experience writing clinical study protocols, CSR, and NDAs/INDs; familiarity with higher-level summaries.

Responsibilities

• Author, co-author, edit, and format regulatory documents (NDAs, CSRs, ICFs) for regulatory submissions.
• Collaborate with cross-functional teams to obtain input for documents.
• Develop and manage medical writing timelines to ensure on-time delivery.
• Lead comment resolution with authors, reviewers, and project teams.
• Oversee vendors/contractors and potentially manage in-house medical writing staff.
• Provide guidance on document content, format, and style for regulatory documents.

Skills

Excellent writing skills

Regulatory writing experience

Attention to detail

Cross-functional communication

Strong editing ability

Knowledge of regulatory guidelines

Education

BA/BS in scientific field

Advanced scientific degree (PhD, PharmD, or MS)

7+ years regulatory medical writing experience

Tools

MS Office (Word, Excel, PowerPoint)

Adobe Acrobat

eCTD knowledge (US/EU)

Veeva Vault / similar document mgmt systems

Job description

Corcept seeks a skilled medical writer to author and edit regulatory documents, including NDAs, protocols, and CSRs, ensuring accuracy and regulatory compliance. You will collaborate with Biometrics, Clinical Operations, and Regulatory Affairs to gather input and lead timelines for on-time submissions.

The role requires a strong background in regulatory medical writing, experience with US/European guidelines, and the ability to lead multiple projects with minimal supervision in a fast-paced