- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations , the Associate Director (AD) is responsible for structuring facilitating and ... 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)
- …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 ... oversight of trial teams. Relationships This position reports to the Director , Clinical Operations . Essential Functions Collaborate with internal stakeholders… 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. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OED; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management: Build strong internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical ... internal and external stakeholders. Relationships This position will report to Senior Director or Executive Director Safety Surveillance, US East Coast… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence ... to maximize your potential with us? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include leading analyses of… more
- Merck & Co. (Rahway, NJ)
- …continued R&D and drive access to life-saving medicines for patients? If so, the Director , Biologics Patent Attorney role , at our Company could be an ideal ... areas of the business including discovery, development, manufacturing, and supply, regulatory , business development, commercial groups, and other legal functions . -… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical ... HAs, ECs, DMCs, and Academia. L ine management responsibility of Director /Associate Director Global Safety Lead, Senior Global Safety Scientist(s)/Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programming documentation filed/archived according to applicable Daiichi Sankyo and regulatory requirements.Communicates with Data Operations leadership, asset ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management … more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The Role.The Director , Privacy Technologist & Third-Party Privacy Risk reporting into the Head of ... liaison with IT&D colleagues to proactively communicate data protection and privacy regulatory changes and their technical impact on IT&D policies and operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical ... Affairs, Marketing, Legal, Quality, and other affiliates. External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia. Individual Contributor Role with no direct reports. Essential Functions Establishment of the product safety profile… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting ... stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of… more
- Merck & Co. (Rahway, NJ)
- …the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management activities, ... practices.Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness.Contribute to the development,… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director , Digital Strategy - Medical/Access/PSS & Paid Media will serve as the ... US. This critical role reports directly to the Senior Director of Digital Strategy and will be expected to...media planning and channel execution experience, marketing & data operations knowledge, and an understanding of the pharma/biotech and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy:… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process qualification, packaging and labeling. This position will interface with Operations , Regulatory , Quality Assurance, Finance, R&D, Project Management and ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...for new products and processes to be included in regulatory submissions.Coordinate and communicate with cross function team members… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
