- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required. Travel Ability ... centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, ... and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items...working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized… more
- American Honda Motor Co Inc (Marysville, OH)
- …assist and support the North American Regional Operating Board (NAROB) and senior executives across North America to strengthen risk management, internal controls, ... AHM Audit also promotes self reliance within NA operations and ensures regulatory compliance while maintaining competitive costs but with the highest quality and… more
- Merck & Co. (North Wales, PA)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director ... talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult ... projectsProvide cross-functional support to Legal Operations as needed Partner with Regulatory Analyst on the submission of all PMRP approved promotional material… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… more
- Aequor (Thousand Oaks, CA)
- …associated with cGMP equipment and facilities at Thousand Oaks (ATO). The senior engineer works in partnership with the automation, maintenance, project management, ... provide data to support business cases and long term strategy. The Senior Engineer role will provide direct engineering technical support as follows: Demonstrating… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Asset Owner. Collaborates with cross-functional teams, including marketing, medical, R&D, regulatory affairs, finance, NNI Global, Market Access (MAPA) and other ... Profile (TPP) Development Support: Provide support for clinical trial strategy, regulatory development, and the development of Target Product Profiles (TPPs) to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist Reporting to the Director, the Senior Specialist Treasury Benefits Finance is responsible for providing ... financial analysis, accounting, reporting, compliance, and funding.Primary Activities:Support the Associate Director in partnering and supporting Human Resources, Legal,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head ... RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams… more
- Merck & Co. (North Wales, PA)
- …Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director, Project Manager, is a core member of Early Drug ... the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle ... within the Respiratory Section of Global Clinical DevelopmentMay serve as a senior therapeutic area content expert within the company, providing input into research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with key roles in Global DX / GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption of metrics. Act as a Liaison ... with one or more clinical systems like CTMS, EDC, eTMF, Planisware, Product Registry, Regulatory etc. required4 or More Years Experience in working with CRO data for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to ... procedures, and regulations, for their assigned TA. The AD partners with senior colleagues in developing and implementing improvements in medical review processes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… 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 strategic direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical issues, ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
