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.
- 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.
- 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.
#LI-
#DI- Ref: #568-Clinical
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