Contractor, Global Drug Safety & Pharmacovigilance Medical Writer
Plainsboro, NJ
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Hybrid
Brand: Joulé
Job ID: 347021
Date Posted: 03/03/2026
Shortcut: http://jobs.systemone.com/xxQKS4
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.
#M-
#LI-
#DI-
Ref: #568-Clinical
-
Technical Writer
Oro Valley, AZ
Job Title: Technical Writer Location: Remote (candidates local to Tucson, AZ preferred) Pay Range: $30.00 - $35.00/hr Type: Contract, Potential for extension or conversion to permanent Formatted Job Description: The Technical Writer is responsible for ...
Date Posted: 01/28/2026 Recommended
-
Site Construction Supervisor
Denver, Colorado
Job Title: Site Construction Supervisor Location: Denver, Colorado Type: 12 months Contract Compensation: $55.00 - $57.00 hourly Contractor Work Model: Onsite System One is currently seeking a Site Construction Supervisor on a 12 month contract positio...
Date Posted: 02/11/2026 Recommended
-
Senior Project Engineer
Cambridge, Massachusetts
Job Title: Senior Project Engineer Location: Cambridge, Massachusetts Type: Direct Hire Compensation: $160000 - $210000 annually Contractor Work Model: Hybrid System One is currently seeking a Senior Project Engineer on a direct hire position located i...
Date Posted: 02/03/2026 Recommended
-
Structural Design Engineer 4
Corvillas, OR
Job Title: Structural Design Engineer 4 Location: Corvallis, OR Type: Direct Hire Contractor Work Model: Remote Position Summary: We are seeking a qualified Structural Design Engineer for a direct hire opportunity. In this full-time, remote role, you w...
Date Posted: 02/23/2026 Recommended
-
Wastewater Project Manager
Boise, Idaho
Job Title: Wastewater Project Manager Location: Boise, Idaho Type: Contract Compensation: $85 - $90 hourly Contractor Work Model: Onsite PROJECT MANAGER Provides direction and management for projects and ensures on-schedule completion within or below b...
Date Posted: 03/03/2026 Recommended
-
Test Design Engineer
Bellevue, WA
Job Title: Test Design Engineer Location: Bellevue, WA Type: Long-term Contract Contractor Work Model: Remote or Onsite Position Overview: We are seeking a highly motivated and skilled Test Design Engineer to join our Instrumentation and Control (I&C) ...
Date Posted: 02/23/2026 Recommended
-
Quality Assurance / Regulatory Affairs (QA/RA) Manager
Jersey City, New Jersey
QA/RA Manager - Medical Device Manufacturing (PRP Products) Location: Jersey City, NJ Employment Type: Direct Hire Compensation: $100,000 – $130,000 annually Schedule: On-site, Monday–Friday Reports to: President & CEO About the Role This role is with ...
Date Posted: 02/03/2026 Recommended
-
Clinical Research Associate/Clinical Research Monitor
Ft Detrick, Virginia
Job Title: Clinical Research Associate/Clinical Research Monitor Location: Ft Detrick, Virginia Type: Contract To Hire Compensation: $70,000-90,000 Contractor Work Model: Hybrid (1-2days onsite) Security Clearance: Must be a US Citizen with the ability...
Date Posted: 02/12/2026 Recommended
-
Clinical Trial Manager - Associate
Burlington, Ontario
Job Title: Clinical Trial Manager - Associate Location: Burlington, Ontario Type: Contract Compensation: $45 CAD Contractor Work Model: Hybrid Clinical Trial Manager - Associate Location: Hybrid, Metro Toronto (Burlington) - 50% per month onsite May St...
Date Posted: 02/24/2026 Recommended
-
Manufacturing Production Supervisor
Fort Stockton, Texas
Job Title: Manufacturing Production Supervisor Location: Fort Stockton, Texas Type: Contract To Hire Compensation: $33 - $35 hourly Contractor Work Model: Onsite Position Overview The Facility / Site Supervisor is a critical leadership role at a Therma...
Date Posted: 03/02/2026 Recommended
-
Sample Management Associate
Tarrytown, NY
Job Title: Sample Management Associate Location: Tarrytown, NY Type: 6-month contract (renewable) Compensation: Up to $40 hourly (dependent on experience) Contractor Work Model: Onsite This opportunity is NOT open to entry level candidates. The qualifi...
Date Posted: 03/02/2026 Recommended
-
CTM/Clinical Trial Manager
Toronto, Ontario
Clinical Trial Manager Location: Hybrid, Metro Toronto (Burlington) - 50% per month onsite 12 months contract Pay: $55 to $70 per hour Job Description: The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the se...
Date Posted: 02/24/2026 Recommended
-
Civil 3D Drafter
San Antonio, Texas
Civil 3D Drafter San Antonio, TX Type: 6-month contract to hire Contractor Work Model: Onsite Summary We are seeking an Associate Engineering Technician to support engineering teams under general supervision. Duties would include technical tasks requir...
Date Posted: 02/26/2026 Recommended
-
Civil 3D Drafter
Houston, Texas
Civil 3D Drafter Houston, TX Type: 6-month contract to hire Contractor Work Model: Onsite Summary We are seeking an Associate Engineering Technician to support engineering teams under general supervision. Duties would include technical tasks requiring ...
Date Posted: 02/26/2026 Recommended
-
Drainage Engineer
Guaynabo, Puerto Rico
Job Title: Drainage Engineer Location: Guaynabo, Puerto Rico Type: Direct Hire Compensation: $72000 - $93000 annually Contractor Work Model: Onsite System One is actively seeking a Drainage Engineer for a direct hire opportunity with a client in Guayna...
Date Posted: 01/20/2026 Recommended
-
Environmental Health and Safety Engineer
San Diego, CA
Job Title: Environmental Health and Safety (EHS) Engineer Location: San Diego, CA Hours/Schedule: Monday–Friday, 8 am to 5 pm (flexibility for early/late hours or occasional weekends as needed) Compensation: $50-58 hourly, DOQ Type: Contract Overview T...
Date Posted: 01/12/2026 Recommended
-
Mechanical Designer / P&ID Designer
Moss Point, Mississippi
Job Title: Mechanical Designer / P&ID Designer Location: Moss Point, Mississippi Type: 12 months Contract Compensation: $32.00 hourly Contractor Work Model: Onsite System One is currently seeking a Mechanical Designer / P&ID Designer on a 12 month cont...
Date Posted: 03/02/2026 Recommended
-
I&C Design Engineer
Bellevue, WA
Job Title: Design Engineer Type: Contract Compensation: $52 - $85 hourly Contractor Work Model: Remote Overview: We are seeking a talented and experienced Design Engineer specializing in Instrumentation and Control (I&C) for a contract opportunity with...
Date Posted: 01/05/2026 Recommended
-
Structural Designer
Birmingham, Alabama
Job Title: Structural Designer Location: Birmingham, AL Type: 3 year Contract Compensation: $36.00 hourly Contractor Work Model: Onsite System One is currently seeking a Structural Designer on a 3 year contract position located in Birmingham, AL. Struc...
Date Posted: 02/26/2026 Recommended
-
Global Supplier Quality Management Representative
Indianapolis, IN
Job Name: Global Supplier Quality Management Representative Location: Indianapolis, IN Work Schedule: Mon - Fri 8am - 5pm Pay Range: $32.60 - $38.35 Type: Contract, Potential for extension or conversion to permanent Overview: The Global Supplier Qualit...
Date Posted: 12/08/2025 Recommended
-
Senior Reactor Operator 4 (Work Control)
Corvallis, Oregon
Job Title: Senior Reactor Operator 4 (Work Control) Type: Contract Contractor Work Model: Remote Location: Remote (within the contiguous United States) Contract Duration: 12-24 months (with possibility of extension) Travel: Required as needed for busin...
Date Posted: 03/02/2026 Recommended
-
Senior Electrical Designer
Birmingham, Alabama
Job Title: Senior Electrical Designer Location: Birmingham, Alabama Type: 3 year Contract Compensation: $46 hourly Contractor Work Model: Hybrid System One is currently seeking a Senior Electrical Designer on a 3 year contract position located in Birmi...
Date Posted: 03/03/2026 Recommended
-
Plant Design Integration Engineer
Bellevue, WA
Job Title: Plant Design Integration Engineer Type: Contract (yearlong) typically extends on a yearly basis Compensation: $56 - $95 hourly Contractor Work Model: Fully Remote Paid Holidays | PTO System One is seeking to contract with a Plant Integration...
Date Posted: 02/12/2026 Recommended
-
Jr Engineer
Mahwah, NJ
Job Name: Jr Engineer Location: Mahwah, NJ Contractor Work Model: Onsite Pay Rate: $26.67 - $38.67/hr Work schedule: Mon- Fri 8am- 5pm Type: Contract Full Job Description: This position is responsible for the analysis and testing of product-representat...
Date Posted: 02/19/2026 Recommended
-
Structural Analysis Engineer
Corvillas, OR
Job Title: Structural Analysis Engineer Type: Contract Contractor Work Model: Remote POSITION SUMMARY: We are seeking a highly skilled Structural Analysis Engineer to apply their technical expertise in performing civil structural analyses and design fo...
Date Posted: 02/09/2026 Recommended
-
Nuclear Digital I&C IV&V Engineer
Corvallis, Oregon
Job Title: Nuclear Digital I&C IV&V Engineer Location: Corvallis, Oregon Type: Contract Contractor Work Model: Remote Job Description: Are you an expert in Independent Verification and Validation (IV&V) with a passion for ensuring the safety and reliab...
Date Posted: 02/23/2026 Recommended
-
Construction Project Manager
Tulsa , Oklahoma
Job Title: Construction Project Manager Location: Tulsa , Oklahoma Responsible for managing and coordinating assigned construction projects from initiation through execution to successful completion. This role involves managing timelines, budgets, reso...
Date Posted: 02/27/2026 Recommended
-
Quality Technician
Bridgeton, NJ
Job Title: Quality Technician Location: Bridgeton, NJ Type: Contract Compensation: $24 - $27 hourly Contractor Work Model: Onsite Hours: 8 AM- 4:30 PM M-F Responsibilities: Evaluate products, raw materials and intermediates for conformance to specifica...
Date Posted: 02/18/2026 Recommended
-
Qualys Vulnerability Management Analyst
Rockville, Maryland
Job Title: Qualys Vulnerability Management Analyst Location: Rockville, Maryland Type: Contract Compensation: $45 - $55 hourly Contractor Work Model: Hybrid Overview: The organization is expanding its Vulnerability Management program and is seeking a h...
Date Posted: 03/02/2026 Recommended
-
Director of IT Mergers and Acquisitions ( IT M&A Director)
Pittsburgh, Pennsylvania
Role : IT Director - M&A Location - Pittsburgh, PA (Hybrid onsite – 3 days a week) Job Description Who will you be working with? As the Director of IT Mergers and Acquisitions, you will work closely with the CIO, VP of IT Strategy and Operational Effec...
Date Posted: 02/05/2026 Recommended