Job Description
Job Title: Contractor, Global Drug Safety & Pharmacovigilance Medical Writer
Location: Plainsboro, NJ
Type: 6-month Contract (renewable)
Compensation: Up to $73/hr (dependent on experience)
Contractor Work Model: Remote but prefer someone that can come to the office occasionally. Since this is a contractor role, the role as confirmed by HR can be remote but it would be nice if the contractor can come to the office occasionally.
Qualifications:
- The engagement would be structured around defined deliverables rather than a full-time position, allowing scalable support aligned with reporting cycles.
- Lead planning and execution of assigned processes/projects (e.g. PMS activities including resource estimation; PV reviews; safety management and review planning)
- Perform regular trending of quality results/observations to identify potential trends or issues and propose long-term strategies for quality improvement or issue resolution
- Perform investigation of deviations and monitoring of Corrective Actions/Preventive Actions (CAPAs) relating to non-compliance issues and findings
- Support development & review of working instructions, SOPs, and job aids for PV systems; and training of end-users as applicable (e.g. PMS education)
- Develop relevant regulatory reports/documents and safety materials (e.g. patient guidance document)
- Provide oversight to vendor activities within area (e.g. data management, query confirmation)
- Participate in implementation and upgrade of PV systems and solutions (e.g. validation documents review, User Acceptance Testing(UAT), E2B testing with regulatory agents and business partners)
- Proactively guide and collaborate with cross-functional teams as a subject matter expert.
- Responsibilities:
- We would like to engage a contractor medical writer under a task-based model to support our aggregate safety reporting activities.
- The immediate priority is technical quality control (QC) of aggregate safety reports, including PSURs/PBRERs, DSURs, RMP updates, and related deliverables, ensuring consistency, accuracy, regulatory compliance, and scientific integrity.
- In addition to QC, this contractor would provide project management support for aggregate reports by maintaining reporting calendars, tracking milestones, coordinating cross-functional inputs, and helping ensure on-time, inspection-ready submissions.
- The role would also provide flexible support to our internal medical writer, including assistance with drafting, document updates, and other aggregate deliverable needs, depending on workload and priorities as needed.
- *Aggregate Safety Report (ASR) Project Management and Medical Writing**
- Lead project management activities for PSURs/PBRERs, DSURs, RMP updates, and other aggregate deliverables.
- Maintain reporting calendars, track milestones, and facilitate cross-functional collaboration to ensure on-time, inspection-ready reports.
- Anticipate risks, identify bottlenecks, and drive efficient resolution.
- Author (medically write) key sections of ASRs, Risk Management Plans (RMPs), signal evaluation reports, health authority responses, and risk-benefit summaries.
- Synthesize complex data into clear, scientifically robust narratives tailored to regulatory expectations.
- Perform QC of deliverables to ensure consistency, accuracy, and scientific integrity.
- Own and maintain ASR processes, SOPs, templates, guidance documents, and training materials.
- Ensure all documentation is updated to reflect evolving global regulatory requirements. Identify and implement process improvements that enhance efficiency and compliance.
- System One, and its subsidiaries including Joulé, ALTA IT Services, and 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.
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Ref: #568-Clinical
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