Contractor - Director, GDS&PV Medical Writer

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

Job Title: Contractor - Director, GDS&PV Medical Writer
Location: Plainsboro, NJ
Type: Contract
Work Model: Hybrid
Pay Rate: $120 an hour W2

Responsibilities

• Support Global Drug Safety and Pharmacovigilance activities.
• Lead the planning, project management, and authoring of Aggregate Safety Reports (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, interpret safety data, 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.

Requirements

• Substantial experience independently authoring complex pharmacovigilance deliverables.
• MD, PharmD, PhD, or equivalent advanced scientific degree.
• Minimum of 10 years of pharmaceutical or biotech medical writing experience.
• Extensive expertise in pharmacovigilance and clinical safety.
• Demonstrated leadership of global regulatory submissions.
• Strong understanding of CTD safety content and health authority expectations.
• Proven success collaborating with Safety, Regulatory Affairs, Clinical Development, and Biostatistics teams.
• Oncology development and submission experience is strongly preferred.
• Direct ownership of DSURs, PSURs/PBRERs, and RMPs (not solely CSR or protocol writing experience).

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#LI-

Ref: #558-Scientific