- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements.Responsibilities Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director ... other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions, as well as building a network with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and ... around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan… 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)
- …analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... statistical methodologies.- Some understanding of current drug development trends and regulatory environments.- Sufficient programming skills in SAS and/or R and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the implementation… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of ... our company.- Position Description/Summary: The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late Drug Development… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …quality checking, and reporting.Communicates effectively with internal team members, senior management, external experts and regulatory authoritiesAuthoring or ... of Clinical Data ManagementJob Grade:G6/G7Department:Biostatistics and Data ManagementFLSA Classification: Manager 's Job Title:Head of BDMDepartment Head Title:Associate VPDoes This… 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
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …way we work every day is important to us.DOWNLOAD OUR CODE OF CONDUCT The Senior Manager , Regulatory Affairs will handle publishing and coordinating tasks ... and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to support the organization's long-term aspirations. Relationships Reports directly to the Sr . Director, Planning, Execution & Operations, with a strong dotted line ... the appropriate cascade from MAPA leadership to our extended partners General: People manager for the MAPA Execution Team Lead short and long-term projects for MAPA… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Manager , Biostatistics This position reports to the local area Lead within Biostatistics and Data Management (BDM) group at SPARC. The main ... DB lock support topline results validation/interpretation, CSR co-authoring and eventual regulatory strategy development and submission. This is a hands-on position,… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …quality checking, and reporting. Communicates effectively with internal team members, senior management, external experts and regulatory authorities Authoring or ... Management Job Grade: G6/G7 Department: Biostatistics and Data Management FLSA Classification: Manager 's Job Title: Head of BDM Department Head Title: Associate VP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development and life cycle management. Represents the function in global regulatory /heath authorities' meetings. High-level negotiation and oversight of CROs and ... career, of direct reports, and mentors or acts as functional manager of staff resides in other offices as needed.Responsibilities:Protocol Development, Statistical… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Manager , Biostatistics This position reports to the local area Lead within Biostatistics and Data Management (BDM) group at SPARC. The main ... DB lock support topline results validation/interpretation, CSR co-authoring and eventual regulatory strategy development and submission. This is a hands-on position,… more
- dsm-firmenich (Princeton, NJ)
- Regulatory Manager / Sr Manager Princeton, NJ Hybrid In this role our ideal candidate will serve as a lead regulatory support for DSM Firmenich's Taste ... deliver exceptional customer service on projects, programs and/or processes to ensure regulatory compliance. At dsm-firmenich, being a force for good is not… more
- dsm-firmenich (Princeton, NJ)
- Regulatory Technical Manager / Senior Manager Plainsboro, New Jersey, USHybrid / Remote / On-Site In this role our ideal candidate will serve as the lead ... regulatory support for DSM Firmenich / Campus ingredients and...customer service on projects, programs and/or processes to ensure regulatory compliance. Monitor and interpret food legislation, ensuring products… more
- Constellation (Pottstown, PA)
- …Alignment\REG & LICENSING\2007 Licensing_NEW\2007 Sit Reg Assur_NEW\XLAH_Prin_Regulatory_Engineer_9107.doc Manager /Director/ Regulatory Assurance Manager and ... This Engineering role can be filled at Mid-level or Senior Engineer level. Please see minimum qualifications list below...for each level Mid Level - $88,200 - $108,000 Sr Level - $115,200- $141,000 Ranges are per year… more
- Terumo Medical Corporation (Somerset, NJ)
- Sr . Product Manager Date: Jun 26, 2024 Req ID: 2511 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Cardiology Terumo Medical ... divisions: Terumo Interventional Systems and Terumo Medical Products. **Job Summary** The Sr . Product Manager will be responsible for all traditional marketing… more
