- Novo Nordisk Inc. (Plainsboro, NJ)
- …documents to FDA .RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout the ... within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... and standardizing data, with a focus on eg, clinical, product , and vendor data and Identify and rectify data...of key industry best practices as well as legislative, regulatory and industry artifacts / frameworks, such as, the… more
- Lundbeck (Stamford, CT)
- …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 ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Lundbeck (El Paso, TX)
- …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 ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Insmed Incorporated (San Diego, CA)
- …managing GMP stability studies across all phases of drug development.Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA ) as they relate ... join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the QC stability and… more
- Merck & Co. (Lenexa, KS)
- …to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies.The successful candidate for this position ... development of vaccination programs and protocol for use of pharmaceuticals, product use directions, adverse event reporting, dealing with Ruminant health issues… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Aequor (Thousand Oaks, CA)
- …the end-to-end labeling processes for the pre & post marketed products over the product 's life cycle. The Labeling Strategist, Manager will lead the development ... Executive Labeling Board the labeling documents review/governance Represents labeling on product -specific global regulatory teams Leads the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is ... those functions. Prepares legal documents such as contracts, correspondence (eg, to regulatory agencies), both independently and for review, approval, and use by… more
- Novo Nordisk Inc. (WA)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, cGMP, USP, and CDR ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Irvine, CA)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What ... report contains the technical merit and completeness according to regulatory expectations. The Deviation Investigator-Writer will be responsible for initiating… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …QA experience Experience in a licensed drug or biologic facility regulated by the FDA , EMEA or a leading international regulatory agency preferred As applicable, ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of materials required for manufacturing and release of patient material/final product of CAR-T at Raritan, NJ Legend manufacturing site.Key Responsibilities Be ... disposition of all incoming materials for use in CAR-T product manufacturing per inspection plan and record results to...handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for… more
- Careerbuilder-US (Glendale Heights, IL)
- …As we continue to grow and expand, we are looking for a dedicated Quality Manager to join our quality team and ensure that our products meet the highest standards. ... Key Responsibilities: Oversee Product Quality: Ensure that all products meet or exceed...or exceed company and customer specifications and meet all regulatory requirements. Manage Food Safety Protocols: Implement and maintain… more
- Alpha Baking (Chicago, IL)
- We are seeking a highly organized and detail-oriented Sanitation Manager to oversee the cleanliness and hygiene of our commercial bakery. As a Sanitation Manager ... adhering to industry sanitation standards, and ensuring compliance with FDA , SQF, HACCP, FSMA, and GMP standards. This position...This position will report directly to the onsite Plant Manager and Regional Food Safety Manager . PRINCIPAL… more
- OSI Group (Oakland, IA)
- …plant strategy including managing tactical quality teams, monitoring and releasing production/ product , and hosting regulatory and customer visits. The overall ... is well integrated. In addition, the Sr. Food Safety/Quality Manager ensures compliance to a combination of product...Required Skills: * 10+ years' in quality assurance and/or regulatory leadership - preferred. Knowledge of GMP/USDA/ FDA … more
- Sysco (Rockford, IL)
- …to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIESMonitoring ... supplier program, foreign material control, plant sanitation, chemical control, product quality assurance, FSQA Customer complaints, food defense and securityAssist… more
