- Utilities Service, LLC (Willow Grove, PA)
- **Description** ** Compliance Investigator - Bilingual English/Spanish preferred** + Conduct Audits and Investigations to ensure compliance with regulations ... Audit compliance with Federal and State regulations with respect to: I-9 compliance , Identity theft, Work Authorization, DOT Compliance , FSLA Compliance ,… more
- ManpowerGroup (Princeton, NJ)
- …one of the largest Pharma companies in the US, is looking for a ** Investigator , MS&T (Manufacturing Science and Technology)** which is located at **Princeton NJ** . ... and expertise in gene/cell therapy manufacturing processes **Job Title:** Investigator , MS&T (Manufacturing Science and Technology) **Location:** Princeton NJ **Pay… more
- System One (Piscataway, NJ)
- Title: QMS Investigator /Supervisor - Quality Control Location: Piscataway, NJ Duration: Contract to Hire Requirements + Bachelor's Degree in chemistry/Molecular ... required. + A good working knowledge of global GxP compliance is preferred. + Excellent time and project management...and accuracy to meet both internal and external regulatory compliance . + Train and assist Junior QC associates in… more
- Novo Nordisk (Plainsboro, NJ)
- …8th, 2025 Scope of Position The individual will be reporting into the Senior Investigator in Ethics & Compliance Investigations. Within this internship role, the ... the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest… more
- Sumitomo Pharma (Trenton, NJ)
- …Research Organizations (CRO) if applicable. This includes oversight of Investigator Initiated Studies (IIS), Collaborative Research and Expanded Access Programs. ... negotiate and finalize the Clinical Trial Agreement and budget with Investigator including documenting milestones + Monitors the progress of IIS/Collaborative… more
- Novo Nordisk (Plainsboro, NJ)
- …budgeting guidance. Collaborating with cross-functional teams to ensure contractual compliance and driving continuous improvement. Works closely with suppliers to ... This role works cross functionally with leaders within CMR, Legal, Procurement, Compliance , Privacy and other key internal stakeholders. In the execution of specific… more
- Merck (Trenton, NJ)
- …interest to the company. The RMSD provides research support to our Investigator -Sponsored and Company-Sponsored Trials to enhance the understanding of the scientific ... patient enrollment and retention efforts for a given study or address Investigator questions. RMSDs also respond to scientific questions from SLs, including… more
- Merck (Trenton, NJ)
- …activities including our Company sponsored trials and our Company Independent Investigator Study Programs as prioritized and requested by our Research Development ... requested by our Research & Development Division's leadership, including our Company's Investigator Study Program (ISP), by acting as the primary liaison to… more
- Hackensack Meridian Health (Edison, NJ)
- …the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned. **Responsibilities** A ... and changes within the protocol. + In collaboration with the principal investigator , clinical research coordinator, and clinical team, participates in the review of… more
- AECOM (Burlington, NJ)
- …(SHPO) documentation pertaining to the cultural resources + Provides regulatory compliance support for Federal, state, municipal and commercial clients + Serves ... experience in directing field crews under the guidance of the Principal Investigator including scheduling work and making individual or team assignments and leading… more
- Philips (Mercerville, NJ)
- …of Clinical Evaluation Reports (CERs), Post Market Clinical Follow-Ups (PMCFs), Investigator Brochures (IBs) documents and the document templates and processes that ... Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) Reports, Investigator Brochures (IBs) for supporting regulatory submissions and studies. +… more
- Sumitomo Pharma (Trenton, NJ)
- …+ Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines + Leads documentation of ... CMC documentation (eg nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed… more
- Ascendis Pharma (Princeton, NJ)
- …phase IV clinical programs including, patient registries, and oversight of investigator -initiated Studies (IISs) as well as Special access programs. The candidate ... team and therapeutically focused commercial personnel (within the boundaries of company compliance SOP's and US regulations) and leads the development and execution… more
- J&J Family of Companies (Horsham, PA)
- …including ReCAP, Advisory Boards, Publications, Methods Review and Collaborative / Investigator -Initiated Study (IIS) concepts + Acts as standing or ad-hoc member ... Experience acting as a liaison to information technology (IT), health care compliance and procurement is preferred + Experience managing publication vendors and/or… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …components of regulatory documents such as Briefing Books (BB), Investigator 's Brochures (IBs), Investigational New Drug Applications (INDs), Clinical Trial ... Applications (CTAs), Investigator 's Brochures (IBs), New Drug Applications (NDAs), Biologic License Applications (BLAs), Marketing Authorization Applications (MAAs),… more
- Merck (Trenton, NJ)
- …for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The Regional Medical Scientific Director serves ... Enhances the comprehension of the scientific foundations and goals of investigator -sponsored research. + Identifies barriers to patient enrollment and retention… more
- Merck (Trenton, NJ)
- …and goals for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The RMSD serves as a role model for ... Enhances the comprehension of the scientific foundations and goals of investigator -sponsored research + Identifies barriers to patient enrollment and retention… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP). **Responsibilities** ... meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Support Fair Market Value process in evaluating study budgets… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows: + Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...of lessons learned from audits and inspections. + Support investigator meetings and CRO-relevant meetings by reviewing and contributing… more
- Bristol Myers Squibb (Princeton, NJ)
- …and strategy, and execution of safety post-marketing commitments and ensuring compliance with global regulatory requirements. **Position Summary / Objective** The ... in order to protect patients, BMS products, and BMS regulatory compliance . **Position Responsibilities** Strategic: Decides Medical Review strategy with regard to… more