- Jazz Pharmaceuticals (Redwood City, CA)
- …and/or Advise on deviations and change control management process. Partner with Quality, Regulatory Affairs, Regulatory Operations and CMC and Labeling ... in inspection readiness forums. Assist with all inspection management activities across Regulatory Affairs, Regulatory Operations and CMC and Labeling… more
- Merck & Co. (Rahway, NJ)
- …Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory ... 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end ...Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the CMC ... post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders...requirements based on internal technical documents provided by Technical Operations or from CMOs to support development program and… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for patient support field teams. This role will oversee program operations , compliance, vendor contracts and relationship management. AD will drive collaboration ... 10+ years of progressive patient support / brand management and/or sales/ operations experience required High level of analytics and insight generation required;… more
- Eisai, Inc (Baltimore, MD)
- …with AIEisai Salary Transparency Language:The base salary range for the Associate , Technical Operations is from :67,700-88,800Under current guidelines, this ... ensure reliability and compliance with company standards and governmental regulatory requirements. Investigates/troubleshoots equipment/instrument issues and/or performance processes. Ensures… more
- Merck & Co. (Durham, NC)
- …and patients on time, every time, across the globe.The Quality Assurance Associate Specialist provides Quality support to manufacturing operations . The ... Job DescriptionQuality Assurance Associate SpecialistOur Quality Assurance group ensures every single material inside our products is manufactured, processed,… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Associate Director, Compliance Operations will be a key member of Eisai's US Ethics & ... Compliance)Eisai Salary Transparency Language:The base salary range for the Associate Director, Compliance Operations is from :167,600-220,000Under current… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Lower Gwynedd, PA)
- Job Description About the Role: -- PDMB provides data-driven operations and automation support to regulated bioanalytical laboratories. We combine laboratory domain ... data platforms to ensure reliable, compliant, and continuously improving lab operations . You'll join a multidisciplinary team partnering with lab scientists,… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJOB DESCRIPTION SUMMARY Primary activities include but are not limited to: The Associate Principal Scientist is a DVM and/or PhD whose primary function is ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This ... a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter expert on the device… more
- Merck & Co. (Rahway, NJ)
- …global businesses units, including those in Manufacturing, Commercial, Technical Operations , Research and Development, and corporate enterprises.As we emerge from ... Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison...design standards, open space and site planning guidelines, and regulatory compliance such as ADA, environmental, and building codes.Ensure… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead.-- ... GxP compliance concerns.Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to incorporate into… more
- Merck & Co. (Rahway, NJ)
- …(as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and ... related to clinical supply planning and incorporate them into the team's operations . Focus on Customers & Patients. Make rapid, disciplined decisions. Demonstrates… more
- Novo Nordisk Inc. (Boulder, CO)
- …of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product ... Functions Lead, manage, and advise all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …we work together to change lives for the better. The Position The Associate Director, Media Relations & Issues Management is accountable for establishing and leading ... interacts with senior leaders across all areas of Novo Nordisk US Operations (USO), including USO President/Executive Office, Commercial, Market Access and Public… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and ... Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to be an industry leader in problem-solving,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Value process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums ... of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Associate Director, Engineering as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Director of ... responsible for the management, development, and performance of all engineering operations across Raritan Carvykti drug product manufacturing. This role ensures that… more
