- 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. (Plainsboro, NJ)
- …Marketing, CX and Marketing Enablement, Market Access, Legal, Compliance , Insights/Analytics, Communications, Finance, and Market Research. External relationships ... and optimizations across both live and self-service support Maintain robust compliance , quality and privacy standards in handling customer information and programs… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EPA, OSHA, and the FDA. Monitors and ensures company compliance with regulatory standards.Excellent organizational and communication skills.#Li-JK2#Li-HybridThe ... Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Partner with all operations work-cells to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes.Serves as ... Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation ... analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… 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 ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities:Reconcile the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, ... and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written… more
- Cardinal Health (Trenton, NJ)
- …GMPD products. **_Job Summary_** In line with Cardinal Health business objectives, the Regulatory Compliance Manager will assist with managing Global ... **_What Regulatory Compliance contributes to Cardinal Health_** Regulatory Compliance develops and implements strategies and standard operating… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required) + 2 or ... as other research areas centered around rare diseases and immune disorders **Job Summary:** The Regulatory Process Manager will be a key member of the Global … more
- Novo Nordisk (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
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Zurich NA (Trenton, NJ)
- RCIS Crop Regulatory Operations & Governance Manager 123791 RCIS (Rural Community Insurance Service), a division of Zurich North America, is currently hiring a ... Crop Operations Manager . This person can work at either the Anoka,...effectiveness of controls, compliance with management directives, compliance with regulatory requirements and efficiency of… more
- CBRE (Trenton, NJ)
- …Risk, Ethics and Compliance job function. They are responsible for overseeing regulatory compliance that balances business and compliance solutions to ... at CBRE, you will be responsible for developing and implementing a comprehensive regulatory change management program to ensure CBRE's compliance with evolving … more
- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Manager , Compliance , Training & Strategic Alliance (CTSA), PVRM** . The ... Associate Manager , Compliance , Training & Strategic Alliance (CTSA),...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Prime Therapeutics (Trenton, NJ)
- …Posting Title** Manager , Compliance - Remote **Job Description** The Compliance Manager works closely with designated business areas, Legal, and other ... changing laws and regulations, accreditation standards, and client contractual compliance obligations, interpret the impact, and manage solutions for designated… more
- System One (Plainsboro, NJ)
- … regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation. QUALIFICATIONS: + A ... Job Title: Regulatory Labeling Specialist Compensation: $95000 - $110000 annually...Affairs, CMR, Supply Chain, and HQ colleagues regarding labeling compliance to accomplish company goals. + External relationships may… more
- Bausch Health (Bridgewater, NJ)
- …progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ regulatory compliance for assigned ... Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory ...+ Manage interactions with other BHC functions (eg, Quality, Compliance ) during Regulatory Authority inspections + Provide… more
