- Novo Nordisk Inc. (Plainsboro, NJ)
- …and SPL) May be responsible for managing projects, processes, or programs with manager oversight Knowledge of FDA and Health Canada eCTD submissions lifecycle ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product Labeling for FDA submission, ... research areas centered around rare diseases and immune disorders. SummaryThe Manager , Regulatory Affairs Labeling position will provide Regulatory support for… more
- Lundbeck (Tucson, AZ)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… 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 ... attain resources and information from established internal contacts; consult with manager for decisions outside of established procedures.Provide direction to the… more
- Merck & Co. (Durham, NC)
- …finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer ... to work cross-functionally with existing Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Assistant Operations Manager will work under the direction of the Operations Manager to provide oversight and administrative support while ... with cGMP, safety standards and good housekeeping standardsAssist Operations Manager in supervising daily operations Determine staffing requirements, work assignment… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary We are seeking a dynamic and experienced Plant Manager to oversee our manufacturing operations. The ideal candidate will have a strong background in ... skills, and a commitment to excellence in quality and safety. The Plant Manager will be responsible for ensuring efficient production processes, managing staff, and… more
- Lundbeck (Minneapolis, MN)
- …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 ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… more
- Lundbeck (Fargo, ND)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Product Supervisor will report directly to quality upper management, (QC Senior Manager ), and will provide both managerial and scientific (hands on) leadership as ... methods for raw material, in-process, and finished product per USP and FDA guidanceProvides work assignments with communication of the expected timelines to… 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 ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …System (BMS) and Environmental Monitoring System (EMS). Relationships Reports to: Manager of Automation Engineering Essential Functions Lead, plan, organize and ... regulatory inspections of BMS and relevant projects as needed Work with the project manager to coordinate the activities and needs of the installation team Work with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functions in connection with convention planning. Relationships Reports to the Manager , Convention Marketing reports to the Associate Director, Convention Marketing ... of the Strategic Meeting & Event Management department. The Manager will have many cross-functional internal relationships including (but not limited) to the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Data Reviewer reports to the Data Review Supervisor or quality management (ie, Manager or Director). The reviewer will be responsible for the review of logbooks ... US Food and Drug Administration.Experience RequirementsKnowledge and experience with FDA regulations.Self-motivated with demonstrated ability to work effectively with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company. [Specific assignments to be determined by direct manager of the role.]- Creates, implements, and presents training programs and materials ... product promotion, scientific exchange, and disease state communications (including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which includes but ... in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA , EMA, and ICH guidance for drug development pertaining to… more
Related Job Searches:
FDA,
Manager,
Manufacturing Manager FDA,
Operations Manager FDA,
Process Manager FDA,
Project Manager FDA,
Quality Compliance Manager FDA,
Quality Manager FDA,
Requirements Manager FDA,
Sr Program Manager FDA