Clinical & Regulatory Writing

Duration: 2 months, with potential to extend/convert

Schedule: 40 hrs/week Relocation: Full relocation package available

Key Responsibilities:

• Lead medical writing activities for clinical and regulatory submissions.
• Independently author complex clinical and regulatory documents.
• Coordinate clinical sections of complex regulatory filings and MAAs.
• Provide strategic guidance across clinical programs and cross-functional teams.
• Lead/manage Medical Writing Science team activities and staff development.
• Drive process improvements, new technologies, and document development initiatives.
• Identify risks and develop solutions to complex regulatory writing challenges.

Requirements:

• Bachelor’s degree in a relevant discipline; PhD or equivalent preferred/required.
• 8+ years of medical/regulatory writing experience.
• 2+ years of supervisory or management experience.
• Strong experience with marketing authorization applications and regulatory submissions.
• Excellent leadership, communication, problem-solving, and project management skills.