- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the ... and regulatory submissions. This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function of the CMR organization. This ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and strategic partnership contracting agreements. In collaboration with the Associate Director, the Associate Manager will support… 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)
- … requirements.Preferred Experience and Skills:Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)Ability and ... Job DescriptionThe Associate Principal Programmer leads the statistical programming activities...includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables,… more
- Novo Nordisk Inc. (Los Angeles, CA)
- 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)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... collaborate to discover the next medical breakthrough.Position Description: The Associate Principal Scientist Statistical Programming leads the statistical programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oversight of vendor delivery, to ensure compliance with the protocol, external /internal standards, applicable regulatory guidelines, Policies, SOPs, and other ... and manage oversight. The position will partner with internal and external stakeholders to optimize Statistical methods, processes and standards. The position… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC ... automation systems.-Integration of control systems with MES, Quality, and Batch Reporting applications.Understand and adhere to CFR, GMP, and data integrity… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director, Omnichannel Marketing and Media position reports to the Senior Director, Omnichannel ... Marketing (HCP and Patient). The associate director will also partner closely with key internal...processes and best practices. He/she manages relationships with agencies, external alliance colleagues and internal business partners to align… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Health, and Safety (EHS) initiatives with a focus on environmental compliance and reporting . Priority reports include air permitting, Tier II & Hazardous Materials ... reporting , and wastewater discharge compliance. Develops and improves site...compliance. Develops and improves site policies, prepares and submits regulatory reports, independently track recurring regulatory reports… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …IT, etc. Other internal relationships include Public Affairs and CMR. External relationships include relations with external consultants, patient support ... patient support programs data strategy aligns with organizational goals and regulatory requirements, working closely with key stakeholders to drive impactful change… more
- Eisai, Inc (Nutley, NJ)
- …systems' roadmaps. Collaborate with global finance for the planning, approval and reporting of budgets and forecasts. Lead the definition of conceptual and logical ... with/using the following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting Regulatory… 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 ... into the piece by agency/initiator Conduct training and provide guidance to internal/ external customers who interact with PMRT in accordance with the AOP; maintain… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other third party vendors to ensure compliance with the protocol, external /internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, ... provides leadership within Data Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... related to plant maintenance and spare parts procurement systems.Working knowledge of regulatory requirements in accordance with GMPs.Ability to work in a highly… 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
- 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
- Catalent (Harman, WV)
- …facility with ten suites actively operating and eight additional suites coming online. Reporting to the Vice President and General Manager, the Senior Director Supply ... recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to procurement.Develop and continuously… more
