- Merck & Co. (Rahway, NJ)
- …and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience with ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effective project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the ... a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop...Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Designers, Marketing and Supply Chain. Relationships Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel within ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...oversee and lead critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects guided… more
- 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 ... on cross-functional teams focused on the planning and execution of regulatory labeling operations . This includes anticipating labeling obstacles, identifying… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… 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)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is the IT… more
- Merck & Co. (Durham, NC)
- …reductions, and standard work at the shop floor level. Collaborates with Operations , Technology and Quality to author regulatory inspection observation responses ... shop floor experience highly preferred. Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/ pharmaceutical industry.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) A minimum of 7 years ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...NACD & Novo Nordisk (eg, across NACD, CMR, International Operations (IO), HQ CDD, & Commercial). Supervisory responsibilities including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) Experience in managing/monitoring ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...various aspects of operational activities within Clinical Development & Operations (CDO). Takes ownership to deliver upon near &… more
- Merck & Co. (Durham, NC)
- …decision-making. Author, review, and/or edit procedures and technical documents to support Operations and regulatory filings. Work alongside operations and ... of the vaccine manufacturing to help eradicate HPV-related cancers. Members of the Operations team in this new and exciting facility will have the unique opportunity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems and Operations Intern to work closely with the Director of Publications Operations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Tris Pharma (Monmouth Junction, NJ)
- …between marketing and other cross-functional teams (ie, Medical Affairs, Sales, Regulatory Affairs, Operations , etc.)Collaborates closely with Analytics team to ... with advocacy organizations and Key Opinion Leaders (KOLs)Strong understanding of pharmaceutical marketing practices including the regulatory environment and… more
- Merck & Co. (Rahway, NJ)
- …experience in leading multiple geographically dispersed sites, matrixed functions, or operations within the pharmaceutical , chemical, or other like ... pharmaceutical or chemical industry.Robust skills interpreting and applying regulatory frameworks such OSHA, OHSAS 18000, EPA, ISO, NFPA, GMP.Strong leadership,… more
- Merck & Co. (Rahway, NJ)
- …in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical /Biotech industry OR Master's degree ... in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical /Biotech industry ORPh.D. in Chemical… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA, as ... (CPIs)Works directly and cross functionally throughout company (ie, QA Operations , Quality Control (QC), Manufacturing, Operations , Technical Services,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Sr Utilities Engineer (Clean Utilities), you will provide cross-functional support to operations , maintenance, quality and project teams for site GMP utilities. You ... site GMP Clean Utilities infrastructure and systems (WFI, Clean Steam, Pharmaceutical /Oil-Free Compressed Air, Process Gases, HVAC, etc.) and applications in aseptic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... within DSI and global entities, advising on legislative and regulatory compliance, lobbying activities, political contributions, public policy development, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… more
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