- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the business functions. Identify appropriate continuous improvement initiatives for quality and compliance related areas. Oversight Provide ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports...product lifecycle process and develop risk mitigation strategies. Provide quality oversight and strategic quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Merck & Co. (North Wales, PA)
- …Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices ... engineering and quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Scientific Communications is a core member of Medical Strategy and ... implementation of global Medical Communications Strategy across regions. The Director will develop collaborative partnerships with the cross-functional Insmed team… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Medical Director of Brensocatib is a key leadership role and will develop, implement, ... thought leader engagement strategic approach and ensuing plan and provide strategic oversight to the cross functional medical engagement plansDeliver high quality… more
- Insmed Incorporated (San Diego, CA)
- …to manage all aspects of clinical operations including study planning, financial oversight , project deadlines and ensuring compliance with Good Clinical ... aspects of gene therapy programs.Responsible for the development of, and the oversight for execution of clinical studies milestones to support company budgets, and… more
- Merck & Co. (Rahway, NJ)
- …are quickly addressed.- Their expertise in SAP Development will include delivery, oversight of standards, and governance.- Their expertise in SAP Security will ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the ... and functional service providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team. The ideal individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with clinical and medical teams, CROs and other vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. ... optimize medical coding processes, technology, and standards. This position ensures quality delivery of medical coding for clinical trials, clinical development, and… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas Infrastructure Director , your role involves collaborating with other Eisai regions and global Enterprise ... a regional infrastructure technology sourcing strategy and provides executive oversight for strategic vendor and partner relationship management.Provide leadership… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operating procedures for statistical programming practice, especially with respect to oversight of vendor performanceOversees compliance with standard procedures ... related to study, project and submissionManage CRO to ensure high quality compound and multi-compound level deliverablesLead the development of global harmonization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Oversight Under limited supervision, responsible for providing direction and execute oversight of vendor delivery, to ensure compliance with the protocol, ... manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversight - Under limited supervision, responsible for providing direction and execute oversight of vendor delivery, to ensure compliance with the protocol, ... (from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operating procedures for statistical programming practice, especially with respect to oversight of vendor performance. Oversees compliance with standard ... related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... management deliverables for all studies within the project/program level meets quality , time and cost effectiveLeads functional and/or multidisciplinary teams… more
- Merck & Co. (Rahway, NJ)
- …is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are ... achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in...o Local Supplier Qualification and verification o Local Supplier Oversight o Our Research Division Country Compliance … more
- Catalent (St. Petersburg, FL)
- …accordance with templates and liaise with site and Suppliers to finalize to allow Supplier Quality Director approval Act as a liaison between suppliers and the ... committed to a Patient First culture through excellence in quality and compliance , and to the safety...their assigned schedule in support of supplier integrity and oversight . The Quality Auditor will be p… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require… more
