Senior Medical Writing Manager | Lead Regulatory Submissions

System One, Inc.; Plainsboro Township (NJ); Hybrid; USD 120,000 - 180,000; Full time

Job summary

System One, Inc. in Plainsboro, NJ, is seeking a Senior Medical Writing Manager for a contract role. You will lead the preparation of complex regulatory documents, oversee timelines, and collaborate with cross-functional teams to ensure submission readiness.

The position requires 6–8+ years in medical writing, expert knowledge of CTD/eCTD, and a proven track record in regulatory submissions. Hybrid work 2-3 days onsite in Plainsboro, with standard 9–5 hours.

Qualifications

• 6-8+ years of medical writing experience in pharma/biotech.
• Experience independently authoring clinical trial protocols and CSRs.
• Strong knowledge of CTD/eCTD and global regulatory requirements.

Responsibilities

• Author and finalize complex clinical and regulatory documents including: Clinical Trial Protocols and Amendments.
• Prepare Clinical Study Reports (CSRs) and Investigator's Brochures (IBs).
• Draft Clinical Overviews and Clinical Summaries.
• Develop Health Authority Briefing Packages and Responses.
• Create and maintain CTD/eCTD submission documents.
• Draft publications and presentations for conferences/publications.
• Ensure documents meet quality standards and regulatory requirements.
• Lead medical writing for assigned compounds and studies.
• Represent Medical Writing on Clinical Trial and regulatory submission teams.
• Manage timelines, review cycles, and approvals.

Skills

Medical Writing

Regulatory writing

Project management

Cross-functional collaboration

Education

Advanced life sciences degree

Tools

CTD/eCTD structure

Regulatory submission tools

Job description

System One, Inc. in Plainsboro, NJ, is seeking a Senior Medical Writing Manager for a contract role. You will lead the preparation of complex regulatory documents, oversee timelines, and collaborate with cross-functional teams to ensure submission readiness.

The position requires 6–8+ years in medical writing, expert knowledge of CTD/eCTD, and a proven track record in regulatory submissions. Hybrid work 2-3 days onsite in Plainsboro, with standard 9–5 hours.