Contractor - Director, GDS&PV Medical Writer
Plainsboro, NJ
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Hybrid
Brand: System One
Job ID: 383256
Date Posted: 11/10/2026
Shortcut: http://jobs.systemone.com/mYdpV9
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
-
Senior Medical Writing Manager
Plainsboro, NJ
Job Title: Senior Medical Writing Manager Location: Plainsboro, NJ Type: Contract Work Model: Hybrid Hours: Monday-Friday, 9:00 AM - 5:00 PM (40 hours per week) Overview Responsibilities Author and finalize complex clinical and regulatory documents inc...
Date Posted: 10/30/2026 Recommended
-
Senior Manager, Medical Affairs Training & Development
Plainsboro, NJ
Job Title: Senior Manager, Medical Affairs Training & Development Location: REMOTE Type: Contract Compensation: Up to $100.00 per hour Work Model: REMOTE Hours: 40 hours per week Responsibilities Support and lead the development, implementation, and co...
Date Posted: 09/24/2026 Recommended
-
Senior Clinical Research Associate
Plainsboro Township, New Jersey
Job Title: Senior Clinical Research Associate Location: Miami/Ft. Lauderdale, FL Type: Contract Compensation: $115,000 - $145,000 Work Model: Remote Hours: 40.0 hours/week Overview We are looking for a Senior Clinical Research Associate (CRA) to suppor...
Date Posted: 11/09/2026 Recommended
-
Senior Clinical Research Associate
Plainsboro Township, New Jersey
Job Title: Senior Clinical Research Associate Location: Durham/RTP, NC Type: Embedded Salaried Compensation: $120,000.00 - $135,000.00 based on education/experience level Work Model: Remote with Regional Travel Hours: 40.0 hours/week Overview We are lo...
Date Posted: 11/09/2026 Recommended
-
Regulatory Affairs Labeling Operations Specialist
Plainsboro Township, New Jersey
Job Title: Labeling Specialist Location: Fully Remote - USA based Compensation: $100k-120k annually (commensurate with level of experience) Type: Long term project, annual salary plus 20 days PTO + 10 Holidays + 401k as well as the option to sign up fo...
Date Posted: 10/27/2026 Recommended
-
Senior Change Management Lead
Sunnyvale, CA
Job Title: Senior Change Management Lead Location: Sunnyvale, CA Type: Contract Compensation: $130-$140/hr Work Model: Remote Hours: 40 hours Overview The purpose of this job is to support Clinical Evaluation Reports (CERs) per Medical Device Regulatio...
Date Posted: 11/12/2026 Recommended
-
Scientist IV, Pharmacology - Contractor
San Diego, CA
Job Title: Scientist IV, Pharmacology - Contractor Location: San Diego, CA Type: Contract Compensation: $79.00 - $102.00 per hour Work Model: Onsite – onsite Hours: 40.0 Responsibilities Design, develop, optimize, and execute in vitro, ex vivo, and in ...
Date Posted: 11/09/2026 Recommended
-
Regulatory Science Senior Specialist
Mahwah, NJ
Job Title: Regulatory Science Senior Specialist Location: Mahwah, NJ Compensation: $48/hr Hours: 8:00am to 5:00pm Type: Contract Overview The role will provide primary technical support for a product transfer project involving orthopedic medical device...
Date Posted: 10/30/2026 Recommended
-
Associate Process Engineer
Mahwah, New Jersey
Job Title: Associate Process Engineer Location: Mahwah, New Jersey Type: Contract Compensation: $40- 45/hr Work Model: Onsite Responsibilities Develops and modifies process formulations, methods and controls to meet quality standards. Recommends and im...
Date Posted: 10/29/2026 Recommended
-
Validation Engineer
Athens, GA
Job Title: Aseptic Manufacturing Validation Engineer Location: Athens, GA Type: 12 month contract Compensation: $45-48/hour, depending on qualifications Work Model: Onsite – onsite Hours: 40/week Overview Support validation activities for aseptic manuf...
Date Posted: 08/27/2026 Recommended
-
Sr. Manager/ Associate Director, Biostatistics
Wayne, Pennsylvania
Job Title: Sr. Manager/ Associate Director, Biostatistics Location: Wayne, Pennsylvania Type: Direct Hire – Full Time Permanent Compensation: $175,000.00 - $200,000.00 Work Model: Hybrid – 2 days onsite Hours: 40.0 Join a growing clinical-stage biotech...
Date Posted: 10/14/2026 Recommended
-
CRA - Monitor Southeast
Philadelphia, PA
Job Title: CRA - Monitor Southeast Location: Southeast USA - Must be based in Atlanta, GA or Orlando, FL or Tampa, FL or Charlotte, NC, or Nashville, TN Type: Contract Compensation: $65-71/hr W2 Work Model: Remote – home office Hours: Part Time - 20 ho...
Date Posted: 10/06/2026 Recommended
-
Technical Regulatory Documentation Specialist
South San Francisco, CA
Job Title: Technical Regulatory Documentation Specialist Location: South San Francisco, CA Type: Contract Compensation: $45-50/hr Work Model: Onsite Responsibilities Provide essential support for document lifecycle management, data entry, and workflow ...
Date Posted: 09/15/2026 Recommended
-
Senior Clinical Research Scientist
Princeton, New Jersey
Job Title: Senior Clinical Research Scientist Location: Princeton, New Jersey Type: Contract Compensation: $110 per hour Work Model: Remote – offsite Hours: 9:00 AM to 5:00 PM, 40 hours per week Responsibilities Contribute to the implementation of the ...
Date Posted: 10/16/2026 Recommended
-
Product Field Action Coordinator
Redmond, Washington
Job Title: Product Field Action Coordinator Location: Redmond, WA Type: Contract Compensation: $24/hr Work Model: Hybrid Hours: M-W onsite; Th-Fr remote. 8-5 Overview Responsible for coordinating Product Field Action Executions according to defined str...
Date Posted: 10/14/2026 Recommended
-
Project Manager IV
Pittsburgh, PA
Job Title: Project Manager IV Location: Pittsburgh, PA 15219 Type: Direct Hire Work Model: Onsite – onsite Overview: Join an exciting new institute in a start-up and growth-stage environment, where ideas are moving quickly and the infrastructure to sup...
Date Posted: 11/06/2026 Recommended
-
CRA - Monitor Texas
Dallas, Texas
Job Title: CRA - Monitor Location: Texas Type: Contract/Part time We are seeking a dedicated Contract Clinical Research Associate (CRA) to join our team on a part-time basis. The role involves monitoring clinical trials within Texas, with a flexible sc...
Date Posted: 10/06/2026 Recommended
-
Senior Clinical Project Manager
Exton, PA
Job Title: Senior Clinical Project Manager Location: Remote Type: Direct Hire Hours: 40.0 hours per week Overview Seeking a highly organized and communicative Senior Clinical Project Manager to lead complex clinical studies, manage vendor relationships...
Date Posted: 09/28/2026 Recommended
-
Staff Application Software Engineer
Weston, FL
Job Title: Staff Application Software Engineer Location: Weston, FL Type: Contract Compensation: $65-$70.96/hr Work Model: Hybrid – onsite and remote Hours: Monday-Friday 8am to 5pm (3 to 4 days on site; 1 to 2 days remote) Overview Our Client is seeki...
Date Posted: 10/07/2026 Recommended
-
Drug Safety Surveillance Analyst I
Johns Creek, GA
Job Title: Drug Safety Surveillance Analyst I Location: Atlanta area locations (Athens, Johns Creek, Gainsville) or (St Joeseph, MO, or Ames, IA) Type: 12 month contract Compensation: $67-70/hour, depending on qualifications Work Model: onsite Hours: 4...
Date Posted: 10/05/2026 Recommended
-
Maintenance Technician - Day
Beloit, WI
Job Title: Maintenance Technician Location: Beloit, WI Type: Full-time Compensation: $72,800 Work Model: Onsite Hours: Work Thursday to Thursday (6pm to 4am) with off Friday to Wednesday Responsibilities Perform electro-mechanical maintenance in a batc...
Date Posted: 11/10/2026 Recommended
-
Biosample Coordinator I
Oro Valley, AZ
Job Title: Biosample Coordinator I Location: Oro Valley, AZ Type: Contract Compensation: $30.00 Work Model: Onsite Hours: Monday–Friday, 8:00 AM – 5:00 PM (Overtime may be required based on business needs) Overview Join a leading organization in the li...
Date Posted: 11/11/2026 Recommended
-
Clinical Data Manager II
Oro Valley, AZ
Job Title: Clinical Data Manager II Location: Oro Valley, AZ Type: Contract - Long Term Compensation: $40 - $55/hr - Commensurate with level of experience Work Model: Hybrid - (minimum 3 days onsite each week) Please W2 candidates only - we cannot work...
Date Posted: 11/06/2026 Recommended
-
UX/UI Designer
Portage, Michigan
Job Title: UX/UI Designer Location: Portage, MI Type: Contract Work Model: Remote Compensation: $55/hr Work Schedule: Monday to Friday 9am to 5pm EST Responsibilities Contributing ideas from early product concepts through launch, you’ll generate creati...
Date Posted: 10/23/2026 Recommended
-
Lab Analyst
Baton Rouge, LA
Job Title: Lab Analyst Location: Baton Rouge, Louisiana Type: 9 Month Contract Pay: $28.00/hr-$30.00/hr Schedule: 12-Hour Rotating Schedule (every other weekend off) Clearance: TWIC required for this site Overview The Laboratory Technician in Baton Rou...
Date Posted: 10/27/2026 Recommended
-
QA Product Manager (Sterile Products)
Florham Park, New Jersey
Job Title: QA Product Manager (Sterile Products) Location: Florham Park, New Jersey Type: Direct Hire Compensation: Work Model: Hybrid – onsite and remote Responsibilities Lead and coordinate end-to-end technology transfer projects for drug substance a...
Date Posted: 10/08/2026 Recommended
-
Electrical Engineer
Weston, FL
Job Title: Electrical Engineer Location: Weston, FL Type: Contract Compensation: $76-$81.61/hr Work Model: Onsite Hours: 40 Responsibilities Lead the electrical design and development of a major robotic subsystem. Translate product and system needs int...
Date Posted: 09/18/2026 Recommended
-
Electrical Engineer
Weston, FL
Job Title: Electrical Engineer Location: Weston, FL Type: Contract Compensation: $72 - $77.41 Work Model: Onsite Hours: 40.0 Responsibilities Lead the electrical design and development of a major robotic subsystem. Translate product and system needs in...
Date Posted: 09/18/2026 Recommended
-
Laboratory Technician
Flanders, New Jersey
Job Title: Laboratory Technician Location: Flanders, New Jersey Type: Contract Compensation: $21/hr Work Model: Onsite – onsite Hours: 7 to 3, or 7:30 to 3:30 M-F Responsibilities Evaluate paint properties using established test methods Perform applica...
Date Posted: 11/05/2026 Recommended
-
Manager Research & Development (R&D)
Columbus, Indiana
Job Title: Manager, Research & Development Location: Columbus, Indiana - Relocation Assistance Type: Direct Hire Schedule: Monday - Friday Day Hours Salary: $125,000-$135,000/year, plus bonus Overview System One is partnering with an innovative manufac...
Date Posted: 10/28/2026 Recommended
⚠️ Protecting Job Seekers from Identity Scams
At System One, your privacy and security are important to us. As job-related scams continue to target job seekers, we want to help you recognize and avoid common recruitment fraud. Identity theft scams often involve individuals, also known as "scammers," posing as recruiters or employers to obtain sensitive personal information, such as Social Security numbers, bank account details, or copies of driver’s licenses, with the goal of stealing identities, accessing financial accounts, or creating fraudulent accounts in a victim’s name.