- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Manager , Regulatory Affairs Labeling position will provide Regulatory ... for global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of ... manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through building positive relationships… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring ... compliance with technical and regulatory standards. This role involves efficient resource management, and clear communication with stakeholders and the project team.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… more
- Aequor (NV)
- …and Workforce Strategy program that currently consists of the E2E Regulatory Content Automation and Regulatory India initiatives. Additional initiatives ... initiatives Support maintaining single source of truth for status of all Regulatory roles being hired in India throughout recruitment, transition, and sustainment… 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
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Operations Team in Princeton ... to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global Clinical Drug Supply Project/Trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within specified therapy… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... supply of API, during the execution of the job duties, the senior manager should seek to actively support continuous improvement initiatives and identify wherever… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …time to understand business goals, strategies, emerging risk areas, and the regulatory landscape, ensuring ability to serve as a knowledgeable and effective ... required A minimum of six (6) years combined pharmaceutical, human resources, legal, regulatory , and compliance experience required OR a minimum of four (4) years'… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ... process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is the IT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drive and shape the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and ... PV/MA Quality).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered to program… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Maintenance/Calibration Manager is a leadership opportunity within the Engineering/Maintenance team supporting a new drug substance manufacturing ... on the team through actions, coaching, and prioritization Participate in safety/ regulatory audits (ie tours, topic discussion) Coach individuals when reporting… more
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business. The Program Clinical Supplies Project Manager serves as the primary program-level Global Clinical Supply point of ... development related meetings.- Working independently, the Program Clinical Supplies Project Manager designs strategic and operational plans for all clinical supply… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Project Manager II is responsible for managing larger, more complex projects or multiple projects simultaneously. This role focuses on driving ... implementing project strategies, and ensuring alignment with business objectives. The Project Manager II serves as a key contributor to the organization, fostering… more
- Novo Nordisk Inc. (Virginia, WA)
- …with superior ability to lead through change. Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD) in the Commercial ... budget within targets Responsible for ensuring and tracking compliance with regulatory /legal mandates Review and audit direct reports' expense reports. Exercise… more
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