- 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 ... related to final printed pharmaceutical labeling for launch and lifecycle management projects guided...regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements Identify labeling… 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 ... advise on mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …by an advanced degree or certificate (eg MBA, JD, PMP) Understanding of pharmaceutical compliance risks and the regulatory requirements that impact ... of six (6) years combined pharmaceutical , human resources, legal, regulatory , and compliance experience required OR a minimum of four (4) years' experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation Physical Requirements ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Affairs, CMR, Supply Chain, and HQ colleagues regarding labeling compliance to accomplish company goals. External relationships may include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …communications experience within regulated industries A minimum of 6 years combined pharmaceutical , legal, regulatory , and compliance experience required OR ... Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical... Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Tris Pharma (Monmouth Junction, NJ)
- …degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology industry in positions of ... New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ,...systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory standards, contributing to the organization's success and regulatory compliance .ResponsibilitiesCoordinate global regulatory dossier generation ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and healthcare related fields is preferred A minimum of eight (8) years combined pharmaceutical , legal, regulatory , and compliance experience required OR a ... Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical... Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy… more
- Lundbeck (Miami, FL)
- …Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... transform lives. Join us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and… more
- Lundbeck (Flint, MI)
- …Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... and transform lives. Join us on our journey of growth!As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our CNS… more
- Lundbeck (Seattle, WA)
- … Environment/ Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures ... lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …resource coordination while working closely with cross-functional teams and leadership. The Project Manager I is responsible for being in compliance with all ... Position Summary:The Project Manager I supports the management of small to...self and direct reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to the organization, fostering innovation and supporting cross-functional teams. The Project Manager II is responsible for being in compliance with all ... Position Summary:The Project Manager II is responsible for managing larger, more...self and direct reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements,… more
- Genmab (Plainsboro, NJ)
- …planning documentation (ie, drug supply plan, milestone tracking, IMP manual, etc.Ensure GxP compliance & regulatory guideline compliance during all drug ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …driving impactful customer experiences is required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market ... to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the...Ensure quality control of marketing content in alignment with compliance standards Continued Improvement: Ensure pull-through of 'test and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs),… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …standardization and efficiencies across Patient Support Programs team Serve as the Compliance and Legal lead, ensuring adherence to regulatory standards and ... potential with us? The Position As the general project manager for Patient Support Solutions, the role focuses on...the product owner for pertinent solutions and as the Compliance and Legal lead to uphold integrity across PSS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics and Data Management… more
- Novo Nordisk Inc. (Virginia, WA)
- …for effectively managing budget within targets Responsible for ensuring and tracking compliance with regulatory /legal mandates Review and audit direct reports' ... with superior ability to lead through change. Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD) in the Commercial… more
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