- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position The Deviation Investigator -Writer is responsible for investigating and writing of deviations to the ... merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations and writing… more
- Catalent (Philadelphia, PA)
- …for "Good Manufacturing Practices" and "Good Distribution Practices"Act as lead investigator for all compliance issues regarding incoming, distribution, returns, ... management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. They will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.Ensure study budget is reconciled with Finance ... oversight, performance, and management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships, developing and maintaining strong communication channels. Leads successful investigator and strategic partnership negotiations in accordance with all ... make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management: Assessing and mitigating… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.Ensure study budget is reconciled with Finance ... oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and other cross-functional and regional stakeholders.Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in ... such as scientific symposium and medical congresses, within legal and compliance regulations.Collaborates across functions to support GMA MI&E activities in order… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with operational deviations and a champion for quality priority principles and compliance within the organization. This is an onsite based role with relocation ... and supervise the deviation investigation team, assign deviations based on investigator skill/experience and deviation type, ensure level-loading of investigator … more
- Merck & Co. (Rahway, NJ)
- …the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the ... approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external… more
- Catalent (Philadelphia, PA)
- …employee safety, will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide customer satisfaction and ... projects and/or tasks and ensuring that all functions are being performed in compliance with SOPs. This is a full-time position: Monday - Friday, days. Catalent… more
- Taiho Oncology (New York, NY)
- …collaboration with Medical Affairs personnel supports data generation in Investigator -Initiated Trials (IITs) and SL/HCP initiated projects. Facilitates the review ... Medical Affairs Department and Taiho organization, including as it pertains to compliance with policies, systems and practices. Possesses and maintains a valid… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the ... with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgets.Collect… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and ... of coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information collection, processing,… more
- BioAgilytix (Boston, MA)
- …Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of data and documentation generated by the Bioanalytical Operations ... by the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator )independently creating reports, plans, and submission documents in support of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and other cross-functional and regional stakeholders. Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in ... slide decks, and other internal training resources, within legal and compliance regulations. Provides training or communication of emerging data (internal or… more
- Eisai, Inc (Nutley, NJ)
- …expected to be a team player, and an advocate for quality, compliance , professionalism, and core corporate values at Eisai. Essential Functions Conceptualization, ... and vendors, develops and maintains client relationships.As project lead/principal investigator has project budget, deliverable and timeline responsibility; identifies… more
- Tris Pharma (Monmouth Junction, NJ)
- …agreements with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities Reviews and/or contributes to ... safety sections of key study documents such as (ie, Investigator Brochures, protocols, statistical analysis plans, informed consent forms, Clinical Study Reports… more
- Lundbeck (Miami, FL)
- …gaps Identifies and facilitates the submission of grant requests and investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request, ... training, documentation, expense reporting, and other administrative responsibilities Ensures compliance with all FDA and Lundbeck requirements Required Education,… more
- Insmed Incorporated (Bridgewater, NJ)
- …associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program ... including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD… more
- Stanford University (Stanford, CA)
- Title IX/ Compliance Investigator **Institutional Equity & Access, Stanford, California, United States** Compliance Legal Post Date Feb 03, 2023 Requisition # ... institutions in the world, has an opening for a full-time Title IX/ Compliance Investigator (hereinafter, " Investigator "). Title IX prohibited conduct… more
- State of Colorado (Denver, CO)
- Labor Law - Compliance Investigator II Print (https://www.governmentjobs.com/careers/colorado/jobs/newprint/4496216) Apply Labor Law - Compliance ... Division of Labor Standards and Statistic is hiring three Senior Compliance Investigator II ("CI II") positions. The Strategic Enforcement Policy and… more
