- Novo Nordisk Inc. (Plainsboro, NJ)
- … Affairs labeling related issues. Relationships Reports to labeling management in Regulatory Operations and Innovation. Develop and maintain positive rapport and ... Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.) Works directly with Regulatory Project Mangers to prepare labeling items consistent with content … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, ... drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical industry.Excellent knowledge of project … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based ... in Raritan, NJ. Role OverviewThe CAR-T Operations Manager is an exempt level position...controls, and maintain permanent inspection readiness and actively support regulatory inspections. This individual will need to build strong… more
- Merck & Co. (Durham, NC)
- …active ingredient, finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the ... concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and… more
- Merck & Co. (Durham, NC)
- …site business processes, such as change control, deviation management, audits and regulatory inspections.- The Manager will be responsible for using principles ... management concepts and techniques as they relate to analytical testing, regulatory requirements for new assay development/validation, project timelines and… more
- Genmab (Plainsboro, NJ)
- …Supply Manager , of the following tasks:Global Clinical Drug Supply Project /Trial ManagementObtain Project /Trial specific information to initiate drug supply ... functional collaboration (ie, project /program and trialsLead/Participate in Clinical Project Supply Team discussionParticipate in regulatory discussions in… more
- Merck & Co. (North Wales, PA)
- …R&D division (our Research & Development Division ) is looking for Product Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient ... and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- Product managers must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… 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. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager of CRA Monitoring Oversight and Excellence is responsible for the support ... monitoring conduct across the DS portfolio. This position will serve to support the project plan of CRA Monitoring Oversight and Excellence and the CSOP as it… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position Responsible for providing consistent, high quality project support, reporting, and budget management in support of the US Talent ... support of US Talent Acquisition function. Relationships Reports to a manager in Talent Acquisition. Responsible for developing and maintaining strong relationships… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drive and shape the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and ... prioritize and focus on the delivery and execution of non- project initiatives within R&D Quality and Global RD/PV QA...QA processes and quality standards for continuous improvement and operations excellence. This may include the review of business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... team, Quality Control, Information Technology, maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …brand attorney and the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products and to specific ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Merck & Co. (Durham, NC)
- …and approve BOM changes and Master Batch Records.Review and approve Operations , Technology, or Automation protocols.Assume project management opportunities, by ... on new or revised processes or procedures.Leads or actively participates in project suite teams, as required.Direct support of regulatory inspections and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Value process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums ... the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to...teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance… more
- LA Care Health Plan (Los Angeles, CA)
- Regulatory Operations Project Manager II Job Category: Administrative, HR, Business Professionals Department: Compliance Location: Los Angeles, CA, US, ... and to support the safety net required to achieve that purpose. Job Summary The Regulatory Operations Project Manager II manages a portfolio of complex … more
- University of Michigan (Ann Arbor, MI)
- Regulatory Project Manager Apply Now **How to Apply** A cover letter is required for consideration for this position and should be attached as the first page ... action employer. **Job Detail** **Job Opening ID** 257783 **Working Title** Regulatory Project Manager **Job Title** Research Compliance… more
- Citigroup (Irving, TX)
- …MiFID, US Fed, Treasury, FDIC and regulations from other central banks and regulatory authorities. + Regulatory risk project management ownership (business ... company. + Professional ability and presence to interact with Senior Bank, Regulatory and Audit Management. + Project management knowledge and experience… more
- Burns & McDonnell (Minneapolis, MN)
- **Description** We are seeking an Environmental Regulatory & Compliance Project Manager with significant consulting experience to manage a variety of ... + Prepare summaries of regulations and determine the applicability to a client's operations . + Interpret and apply regulatory requirements, guiding clients in… more
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