- 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...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning, coordination, and implementation of Development SOP activities to ensure regulatory compliance and cross functional cohesiveness across SOPs and ... Director , Development SOP Management Join a...of view and provide guidance to authors to ensure regulatory compliance , consistency and connectiveness across SOPs.… 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, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Accounting, Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This ... of a company poised for continued growth. These responsibilities will include management of all day-to-day payroll operations and activities for all US (multi-state)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to 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...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance objectives Works collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop healthcare compliance ... is preferred A minimum of eight (8) years combined pharmaceutical, human resources, legal, regulatory , and compliance experience required OR a minimum of six (6)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... financial milestones and related payment schedules) Advanced knowledge of Regulatory and Compliance requirements related to Pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …against contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory requirements Fiscal management : Demonstrate ... marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public… 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 ... maximize your potential with us? The Position The Associate Director will be the lead who is responsible for...and platform support). Essential Functions Partners with PSS Program Management team to ensure vendor compliance with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, implementing measures and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the appropriate use of data across the enterprise, in partnership with Legal, Compliance , Privacy and other critical functions. The Director will help integrate ... Legal, Compliance and Privacy Support data cataloging and metadata management responsibilities Promote data literacy and governance awareness across NNI Monitor… more
- Genmab (Plainsboro, NJ)
- …to enhance efficiency and productivity across the organization.Collaborate with legal and compliance teams to ensure adherence to all regulatory requirements and ... and growing organization? At Genmab, we're seeking a Senior Director , Strategic Planning & Effectiveness to drive cross-functional communication, alignment… more
- Genmab (Plainsboro, NJ)
- …technical skill development.Oversee resource allocation and ensure effective team planning. Regulatory and Audit ComplianceEnsure compliance with country-specific ... fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of...ability to exercise their skills and knowledge on process management & improvement, strategic & risk management … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs Develop and implement knowledge management technology ... existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve… more
- Genmab (Plainsboro, NJ)
- …working in agile and product-oriented development teamsSolid experience with Compliance ( regulatory and industry-specific) and Security frameworksDemonstrated ... and authentic is essential to fulfilling our purpose.Job Description - Director , Digital Assets, Information SecurityPosition Summary: The Director Information… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of the pharmaceutical industry including marketing, medical, access, public affairs, compliance , legal and regulatory as well as the healthcare ... as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility as well as… more
- Genmab (Plainsboro, NJ)
- …and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part of our IT & ... IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products. The Solution Architect will… more
