- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory ... works with ambiguity and complex problems, focusing on strategic and operational decisions.ResponsibilitiesActs as point of contact for cross-functional teams on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in a growing ... Operations Department that manages multiple early to late-stage clinical programs. The Associate Director role will be responsible for all aspects of clinical trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include brand marketing, market access, Enterprise Insights, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory @requirements Fiscal Management Demonstrate fiscal discipline… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …improvement initiatives across the organization.This role will focus on driving operational efficiency, ensuring compliance with industry standards, and ... centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director, GMP QA Process Excellence is accountable to...in the analysis and redesign of business processes. Ensure compliance with regulatory standards (eg, ICH, FDA,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External relationships include Patient ... core operations and develop insights to drive growth and operational excellence across the value chain while innovating for...to maximize your potential with us? The Position The Associate Director will be the lead who is responsible… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently seeking an Oncology Competitive Intelligence Associate Director. This role is responsible for providing Competitive Intelligence (CI) ... assessments, such as market situation analysis, strategic forecasting, and operational benchmarking.Monitoring and benchmarking strategic plans and insights of our… more
- Merck & Co. (Rahway, NJ)
- …individual to join our Biologics Process Development Department as an Associate Principal Scientist.- Applicant must have effective organizational and multi-tasking ... scalable cell culture processes.Responsible for process development, process characterization, and regulatory filing activities to ensure a smooth and clear path to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and ... submissions and NDAs Regular updates with key cross-functional partners (Discovery/Late-Stage/ Regulatory ), as well as other disciplines Establish novel endpoints for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and … more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …the rights and well-being of patients; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent ... delivers high quality data and clinical supplies. This position reports to the Associate Director of Global Clinical Supplies Quality and is critical to maintaining… more
- Merck & Co. (Durham, NC)
- …interpersonal, leadership , and collaboration skills responsible for s upporting Operational Readiness projects to support biological processes for a new ... product at a competitive cost consistent with our company, Regulatory Agency , and State and Local code requirements...business plan; receives gui dance and oversight from Operations Associate Director and Director ; - - Interprets client… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position The Associate Director, HCP Experience has overall strategic and operational responsibility as well as tactical pull through of all efforts for Health ... understanding of the pharmaceutical industry including marketing, medical, access, public affairs, compliance , legal and regulatory as well as the healthcare… more
- Merck & Co. (Durham, NC)
- …work environment with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through ... have the safest and most compliant operation around the network.EMSS has an Associate Director opening for the Bulk Facility (GBF) maintenance team. The selected… more
- Merck & Co. (Durham, NC)
- Job Description Job Description: - We have an exciting opportunity for an Associate Specialist to join the technical operations team for our company in Durham, North ... lyophilization, product inspection, and quality control laboratories. - The Associate Specialist, Technical Operations engineer is responsible for providing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our ... will focus on maintaining House in Order by ensuring compliance with Sarbanes Oxley and Novo Nordisk Corporate Accounting...in accordance with IFRS regulations. Relationships Reports to the Associate Director of Accounting at Novo Nordisk Inc. As… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/ Metabolism Section Head in the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development ... reports, and background documents for internal use or for submission to regulatory agenciesInterfaces with functional experts across the enterprise to ensure … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities: Perform ... and Standard Operating ProceduresWear gowns properly following the standard operational procedures and ensure its integrity during manufacturing activitiesEnsure the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trials from protocol finalization through closeout. Relationships Reports to: Associate Director or Director of Clinical Operations. Essential Functions Oversee ... of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating to… more
- Merck & Co. (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... and patients on time, every time, across the globe. The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality of… more
