- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality Compliance ... a health authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP/ regulatory roleStrong background in data… more
- Aequor (Swiftwater, MN)
- …interface between M&S, MSAT and GRA. The Regulatory CMC Specialist will ensure Regulatory compliance by providing support to batch release by checking ... submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing...site registrations. The incumbent also ensures the role of regulatory expert for regulatory topics… more
- Merck & Co. (Rahway, NJ)
- …leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed productsReview and ... strategies that facilitate speed-to-market and the delivery of targeted product labelingProvide expert advice as the Global Regulatory Lead to Product… more
- Merck & Co. (Rahway, NJ)
- …leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.Review and ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our… more
- Merck & Co. (North Wales, PA)
- …review and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that ... promotional practices are consistent with regulatory guidelines, our company's policies, and support ...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... deviation requests for Daiichi Sankyo and partner companies, if applicable.Ensure Compliance with Labeling Regulations and Guidances: Demonstrate expert … more
- Merck & Co. (Upper Gwynedd, PA)
- …proactively and result in outcomes that demonstrate the Company's commitment to regulatory compliance .Ensures that a cross-functional team (eg Quality & ... and Clinical Safety (GRACS), IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.In collaboration with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supply, Regulatory Affairs (NNI/NNCI) marketing, legal and NNI Patient Support Solutions. Essential Functions Accountability: Will serve to represent the Patient ... and activities are compliant with NAO regulations and NAO regulatory authority and inspectors' expectations; Ensure compliance ...as well as with company objectives Liase with Patient Support Solutionsto ensure compliance with Service Level… more
- Eisai, Inc (Nutley, NJ)
- …assesses and provides objective risk assessments and guidance regarding Eisai's compliance with regulatory , organizational, and commercial requirements that ... compliance initiatives (strategic and execution).Assess and guide on compliance with regulatory , organizational, and commercial requirements.Define and… more
- Merck & Co. (Rahway, NJ)
- …all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The ... processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support… more
- Merck & Co. (Rahway, NJ)
- …of experimental designs, execution of experimental plans and data analysis Support both early and late-stage development candidates, including screening and ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Build deep fundamental knowledge around the drug… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process changes/improvement.Partner with all stakeholders to implement process improvements.Assure regulatory compliance and technical feasibility of proposed ... and assess product quality impact. This individual will provide technical support to the investigators and resolution of deviations and atypical events.… more
- Merck & Co. (Rahway, NJ)
- …critical business needs, which can include impact of the external business, regulatory , and compliance environment. Promoting our company's scientific excellence ... parts of the AR&D organization in aspects of quality control and compliance . Your main responsibilities will include: - Strategy and Operational Excellence: Driving… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of the pharmaceutical industry including marketing, medical, access, public affairs, compliance , legal and regulatory as well as the healthcare ... and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch Office,… more
- Merck & Co. (Rahway, NJ)
- …and background documents for internal use or for submission to regulatory agenciesInterfaces with functional experts across the enterprise to ensure operational ... of Global Clinical DevelopmentMay serve as a senior therapeutic area content expert within the company, providing input into research and business development… more
- Eisai, Inc (Dallas, TX)
- …a biopharmaceutical manufacturer capacity)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated success in leading ... multidisciplinary matrix team within Eisai.Advanced understanding of pharmaceutical manufacturer compliance & regulatory requirementsAbility to operate a motor… more
- Merck & Co. (North Wales, PA)
- …clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Evaluating pre-clinical and translational work ... marketed Oncology drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA). Support coordination of data collection and trend ... analysis as requested by QA and Regulatory Affairs including the annual report and continued process verification (CPV)Recognize and act on potential compliance … more
- Merck & Co. (North Wales, PA)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May Be Responsible ... marketed Oncology drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug… more
