Director, GDS&PV Medical Writing (Contract) – Hybrid

System One, Inc.; Plainsboro Township (NJ); Hybrid; USD 136,000 - 194,000; Part time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) plan

Spending accounts

Voluntary plans

Job summary

System One, Inc. is seeking a Contractor - Director, GDS/PV Medical Writer in Plainsboro, NJ.

The hybrid role pays $120 per hour (W2) and leads global pharmacovigilance writing efforts across ASRs, DSURs, PSURs/PBRERs, RMPs, and related safety documents. The successful candidate will independently author complex deliverables, manage cross-functional reviews, and provide scientific leadership across multiple programs while collaborating with Safety, Regulatory Affairs, and Clinical Development

Qualifications

• Substantial experience independently authoring complex pharmacovigilance deliverables.
• Demonstrated leadership of global regulatory submissions.
• Strong understanding of CTD safety content and health authority expectations.

Responsibilities

• Support Global Drug Safety and Pharmacovigilance activities.
• Lead planning, project management, and authoring of ASRs, including DSURs, PSURs/PBRERs.
• Author Risk Management Plans, signal evaluations, benefit-risk assessments, health authority responses, and other regulatory safety documents.
• Independently author complex pharmacovigilance deliverables and drive cross-functional reviews through submission readiness.
• Lead aggregate safety reporting strategy.
• Integrate and evaluate safety evidence from clinical trials and post-marketing sources.
• Author regulatory documents and manage timelines and stakeholder reviews.
• Develop SOPs and templates.
• Serve as the medical writing lead on cross-functional development teams.
• Independently own complex deliverables and provide scientific leadership across multiple programs.

Skills

Leadership

Cross-functional collaboration

Regulatory submissions

Education

MD/PharmD/PhD or equivalent

Job description

System One, Inc. is seeking a Contractor - Director, GDS/PV Medical Writer in Plainsboro, NJ.

The hybrid role pays $120 per hour (W2) and leads global pharmacovigilance writing efforts across ASRs, DSURs, PSURs/PBRERs, RMPs, and related safety documents. The successful candidate will independently author complex deliverables, manage cross-functional reviews, and provide scientific leadership across multiple programs while collaborating with Safety, Regulatory Affairs, and Clinical Development