- Merck & Co. (Rahway, NJ)
- Job DescriptionThe regulatory operations senior specialist supports cross-functional or departmental projects related to regulatory operations. This role ... affairs team as necessary. Implement and maintain processes to ensure compliance with electronic submission formats and global regulatory standards, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks Creatively advise ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion. Essential… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related fields is preferred A minimum of eight (8) years combined pharmaceutical, legal, regulatory , and compliance experience required OR a minimum of six (6) ... the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest… 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. (Durham, NC)
- …standards within the assigned process Provide coaching to Site regarding quality & compliance related activities Facilitate sharing of regulatory & compliance ... Shift. Responsible for the production activities & validation. Ensuring relevant compliance issues are addressed & handled in close collaboration with production.… more
- Novo Nordisk Inc. (Durham, NC)
- …within the assigned process Provides coaching to Site regarding quality & compliance related activities Facilitates sharing of regulatory & compliance ... is responsible for the production activities & validation. Ensures relevant compliance issues are addressed & handled in close collaboration with production.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities Prior TMF… more
- Novo Nordisk Inc. (Durham, NC)
- …process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus & ... Standards "Gatekeeper". Relationships Manager , Technical Support - OFP Essential Functions Work primarily...Problem Solving, process improvement, & project management Operate within compliance with a Quality Mindset that focuses on risk… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... and agencies. Ensure quality control of marketing content in alignment with compliance Continued Improvement: Ensure pull-through of 'test and learn' principles by… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP CX Manager -CV/Renal will be a critical driver in ensuring the successful execution of brand/therapy ... material. Ensure quality control of marketing content in alignment with compliance standards Continued Improvement: Ensure pull-through of 'test and learn'… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …groups within DSI and global entities, advising on legislative and regulatory compliance , lobbying activities, political contributions, public policy ... investments, companion diagnostic, academic research organization, and acquisition deals. Advises senior management on legal and regulatory issues, leads complex… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... in the pharmaceutical or biotechnology industry (including minimum 2 years as a Senior Product Manager or equivalent) in positions of increasing strategic and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years of post-law school experience required4 or More Years experience in regulatory , compliance , and legal matters relating to investigational products, product ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The SQE Manager , QA Compliance , is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ... with all CFR, USP, cGMPs, and SOPs. SQE Manager , QA Compliance will rely on experience...compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensuring the highest standards of scientific integrity, patient safety, regulatory compliance , and collaboration across therapeutic areas. Ultimately, this ... Global Development leadership team on occasion. May interact with senior leaders/leadership, on occasion. Essential Functions Stakeholder Management Ensure effective… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Finished Product Supervisor will report directly to quality upper management, (QC Senior Manager ), and will provide both managerial and scientific (hands ... products in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. The individual will be… more
- Scotiabank (New York, NY)
- Senior Manager , IT Regulatory Compliance Oversight **Requisition ID:** 217554 **Salary Range:** 117,400.00 - 224,700.00 _Please note that the Salary ... every future! **Purpose** This role will serve as a Senior Manager in the Technology Governance Office,... in the Technology Governance Office, primarily leading the regulatory compliance oversight and reporting function for… more
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