- Novo Nordisk (Plainsboro, NJ)
- …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... professional having a wide range of experience and a complete understanding of Regulatory Labeling roles and responsibilities + Demonstrates full knowledge of… more
- Novo Nordisk (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...potential data/claims with manager oversight + Participate/assist in US labeling negotiations as necessary. Ensure that changes in US… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, PV Sciences Princeton, NJ, USA Req #444 Thursday, February 27, 2025 Looking for a chance to make a meaningful difference in the oncology space? ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of...Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials. +… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, PV Medical Surveillance Princeton, NJ, USA Req #435 Tuesday, February 11, 2025 Looking for a chance to make a meaningful difference in the ... concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance. + Responsible for… more
- Merck (West Point, PA)
- …portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The ... a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to ... over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel,… more
- Integra LifeSciences (Plainsboro, NJ)
- …in ensuring that products meet the required safety, performance, and regulatory standards before they reach the market. Their responsibilities typically include: ... visual, mechanical, and sometimes functional tests to ensure products meet regulatory requirements (such as FDA or ISO standards). Documentation and Reporting:… more
- Fresenius Medical Center (Philadelphia, PA)
- …philosophy. Adheres to the Organization's Compliance Program, including following all regulatory and policy requirements. Assists physicians in performing a variety ... + Draws up intravenous medication and labels as per the organization's medication labeling policy. + Processes x-ray images and archives to the image repository, CD… more
- Integra LifeSciences (Plainsboro, NJ)
- …ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical ... test records. + Perform line clearances and quality reviews in manufacturing, labeling , or other assigned areas during manufacturing activities. + Identify and… more