- 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
- Insmed Incorporated (San Diego, CA)
- …strong partnerships.Develop and maintain appropriate metrics to assess performance, compliance and cost effectiveness.Leads investigator meetings, kick-off ... operations including study planning, financial oversight, project deadlines and ensuring compliance with Good Clinical Practices as well as federal and local… 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)
- …support to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, Managed Access programs and Collaborative Research to the ... considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate with other GxP quality representatives and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a US IIS Review Committee, for ... communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.Note that vendor management is not limited to the ... bring deviations to the supervisor. Review and approve Vendor invoices, including investigator grants and pass-through costs.Provide oversight of the CRO to ensure … 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).Responsibilities- Reconcile ... with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect… 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
- 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
- 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
- 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
- SWCA Environmental Consultants (Austin, TX)
- …or research-oriented supervisory experience can substitute for a portion of compliance -based experience.Experience with and thorough knowledge of NEPA, Section 106, ... offices across the United States, SWCA is one of the largest environmental compliance firms and ranks among Engineering News-Record's Top 200 Environmental Firms. If… more
- Eisai, Inc (Nutley, NJ)
- …advisory boards, health outcomes plans, MSL activities, speaker programs, investigator -initiated research and CME grant reviews or other internal key ... business processes.Continuously ensures compliance with Eisai policies and procedures for all activities undertaken and monitors various government and industry… 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
- 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
- Lundbeck (Boston, MA)
- …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
- 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
- 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
- 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
