- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... 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
- BioAgilytix (Durham, NC)
- …in the update, enhancement, and creation of internal policies and proceduresSupports regulatory compliance to ISO, FDA, and other worldwide regulatory ... you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… more
- Aequor (Newbury Park, CA)
- …archival systems/electronic document repositories also useful. Coordination and execution of regulatory submissions in compliance with corporate standards and ... and deliverables. Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of regulatory … more
- Eisai, Inc (Nutley, NJ)
- …security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory , ... educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Catalent (St. Petersburg, FL)
- …, and to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management ... Compliance ManagerPosition SummarySt. Petersburg is our primary softgel...Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThis position will be part of the Compliance organization and will report directly to the Director, Compliance ... be responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning modules. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance to change control process requirements across NN Boulder Develops and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Eisai, Inc (Nutley, NJ)
- …Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with ... and summary reports for submission to the FDA and International Regulatory authorities.Interface with other Eisai Departments and affiliates for dissemination of… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for...- that impact the efficiency and effectiveness of own unit; Compliance - Responsible for creating and sustaining a culture… more
- Merck & Co. (NE)
- …performance of animals and the people who care for them.The Territory Sales Manager - Livestock ID Infrastructure are responsible for establishing and driving the ... the overall company's Animal Health Livestock sales strategy. The Territory Sales Manager - Livestock ID Infrastructure will work alongside the cattle territory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... operations team for the site.- The Manager will direct a team of hourly personnel who...NJ and is a 12-hour rotating shift. Position Duties: Compliance - Accountable for creating and sustaining a culture… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cataloging, archiving, metadata tagging, content management systems, etc. in Adobe Experience Manager (AEM) DAM. The DAM Librarian plays a vital role in the ... multiple NNI internal functions such as Brand Managers, Omnichannel teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors… 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. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tax compliance Collaborate with Legal and Finance stakeholders to ensure compliance with regulatory requirements and internal policies Work closely with ... As a member of the Total Rewards CoE, the Global Employee Shares Manager will be responsible for managing and administering the company's global employee share… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
