- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible ... Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report...Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product ... and trends with effective and statistically sound CAPA plans and issue resolution.The Senior Director will ensure stewards have the appropriate processes and… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and ... Job DescriptionOur company is a global health care leader with a diversified portfolio...colleagues while developing and expanding your career. - The Senior Director ( Senior Principal Scientist)… more
- Merck & Co. (Rahway, NJ)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Director ( Sr . Principal Scientist) has primary responsibility ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Merck & Co. (Rahway, NJ)
- …commercialize complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP Operations, will oversee laboratory compliance ... and track internal compliance metrics and report the observed trends to senior management.Provide regulatory support by preparing or reviewing high-quality CMC… more
- Merck & Co. (Rahway, NJ)
- …Description Job Description: - The 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… 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 ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions.Lead the Device Development… more
- Merck & Co. (Rahway, NJ)
- …oncology compounds.-The Executive Director /PDT lead may:-Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development ... indication of interest.Work closely with a cross-functional Senior / Executive Director group of experts in commercialization, regulatory affairs, statistics,… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate Corporate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi... global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… 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)
- …external partners and vendors' performance through appropriate metrics. In partnership with Sr . Director and procurement, negotiate and execute contracts / SOWs ... the opportunity to build a life-changing career in a global business environment. We encourage our employees to make...and Market Research. The position has high exposure to senior management and requires a highly motivated individual who… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scale as the organization and contact volume grows. Relationships Reports to the Sr . Director , Patient Support Solution Quality/Safety Associate Director . ... the opportunity to build a life-changing career in a global business environment. We encourage our employees to make...maximize your potential with us? The Position The Associate Director will be the lead who is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and share with study team, Operations Program Lead, and Sr . Director for the compound, on regular… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Therapeutic Areas). They are responsible to ensure alignment to global and HR training and onboarding plans. They will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing relationships with internal… 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
