- Catalent (St. Petersburg, FL)
- Manager, QA ( Product Development )Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... Quality Unit and could include all or some aspects of the Quality function.The Product Development QA Manager provides quality focused customer service, with the… more
- Merck & Co. (Rahway, NJ)
- …Computer Science, or related field. Required Skills - Minimum 5 years of experience in product development and road mapping ability to define product vision, ... Compliance and Security Value team. - The Technical Product Manager plays a critical role in implementing, managing,...set strategic goals, and drive product development throughout the lifecycle. - 5 or more years… more
- Insmed Incorporated (Columbus, OH)
- …for authentic and experienced Therapeutic Specialists with demonstrated success in new product launches who are committed to our mission to transform the lives ... of trust, respect, and commitment to winning the right way (culture of compliance ) Foster an entrepreneurial spirit with a focus on ownership and accountability to… more
- Eisai, Inc (Nutley, NJ)
- …medicine/pharmacy, including a minimum of 3 years experience in International Product SafetyKnowledge of Clinical Development process in Pharmaceutical ... and oncology, with a strong emphasis on research and development . Our history includes the development of...to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Catalent (St. Petersburg, FL)
- …etc.Provides project support (wet chemistry and instrumental testing) for new product development .Additional duties as assigned.The CandidateAssociate in Science ... Associate Scientist I, Analytical Research & Development Position SummaryCatalent is a global, high-growth, public company and a leading partner for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and tracking of product samples to healthcare professionals, ensuring compliance with regulations and company policies. Collaborate with supply chain ... and implementation of the training programs for the field team, incorporating product knowledge, selling skills, and compliance guidelines. Evaluate training… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... running the ML teams efficiently and in accordance with compliance practices: That FD's conduct random audits of the...therapeutic area and NNI clinical plans and study results, product support letters, and the Marketing and Sales … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health ... Authority labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... alignment with educational priorities and manage Novo Nordisk supported IME programs in compliance with external IME industry regulations and guidelines as well… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Develops, executes and monitors Trade-driven programs within the channel to improve product reimbursement, awareness, pull through, and compliance Acts as ... Strong knowledge of US Pharmaceutical distribution, third party logistics, channel compliance , and buy side economics, distribution regulations Excellent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to support implementation and execution of diagnostic initiatives Diagnostic Health Product Execution: Drive the development and implementation of diagnostic ... is leading a complex role in understanding current diagnostic ecosystem, market development related to diagnostics and more efficient approaches to finding patients.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with the manufacture of product Support in-process activities and product development when instructed by supervisor Incorporate pre-planned process ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. For… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo...counterparts to promote quality and consistency across regions. Ensure compliance with SOPs, KPIs, internal processes; Track and measure… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... is preparing for the potential launch of a new product in the US focused on a treatment (if...meetings as neededLead and coach all daily activities in compliance with Eisai policies.Manage the resolution of operational conflicts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo...training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... Nordisk compliance with internal SOPs and Federal and State regulations , including compilation and submission of any required documents to regulatory agencies.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... investigator and strategic partnership negotiations in accordance with all relevant regulations and policies; (Good Clinical Practice (GCP), ICH guidelines, federal … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …schedule and lead day-to-day QC Microbiology activities for routine in-process and product testing ensuring compliance , accuracy and timeliness of testing ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of... current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and… more
- BioAgilytix (Durham, NC)
- …complex or unique issues and challenges regarding registration and compliance activitiesReviews, interprets, and communicates FDA/international regulations and ... internal documentation, notification of change, supplemental submission)Advise on impact of regulations , devises strategies for compliance and acts as liaison… more
