Associate Director/Director, Medical & Regulatory Writing

📋 Description

• Serves as subject matter expert in preparing clinical regulatory documents through all phases of
• Represent medical writing in cross-functional team meetings.
• Collaborate with department heads and staff members of cross-functional groups, including clinical
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement and maintenance of medical writing work practice documents
• Oversight of vendors including contract writers, QC reviewers, and document formatters.

🎯 Requirements

• Bachelor’s, Masters or PhD Degree in scientific, medical, clinical discipline or related field is
• A minimum of 10-12 years of relevant industry experience as a medical writer in a pharmaceutical
• Experience authoring clinical study reports, protocols, protocol amendments, and Investigator’s
• Experience authoring and managing briefing books is a plus.
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus.

🎁 Benefits

• Career advancement/development opportunities
• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan