- 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...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… 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 ... areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …preferred Advanced knowledge of pertinent FDA regulations Broad hands-on related pharmaceutical experience and FDA regulatory experience; subpart H experience ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… 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
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The ...in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … team based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous ... a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop...in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …shape the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and ... Quality ).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered to program… 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 ... around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical...safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and clear communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high- quality deliverables, and ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex… 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 ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… 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...materials, including coordination with external suppliers and agencies. Ensure quality control of marketing material. Ensure quality … 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
- 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. SummaryThe Manager , Medical Review, will have responsibility for medical review within their… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical ... entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize… more
- Merck & Co. (Durham, NC)
- …with strategic direction facilitated by our global business model and regulatory compliance.--General Profile:Investigation of Product Quality Complaints and ... relevant scientific disciplineMinimum of five (5) years' experience supporting pharmaceutical manufacturing/ quality management systemsDemonstrated ability to independently… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to maximize your potential with us? The Position As the general project manager for Patient Support Solutions, the role focuses on not only leading projects ... team Serve as the Compliance and Legal lead, ensuring adherence to regulatory standards and integrity across all PSS programs. Physical Requirements 0-10% overnight… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reviews and authoring reports and co-authoring primary and secondary sections of regulatory documents. The Manager , Clinical Pharmacology is expected to ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of deviances and variances that occur during production or validationWork with Quality , Manufacturing, Regulatory , and subject matter experts to prepare for ... topics to a non-technical audienceAt least 8 years' experience in the biotech/ pharmaceutical industry in validation, quality management, process controls, and… more
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