- Eisai, Inc (Exton, PA)
- …and other internal (PST) and external functions to support successful product development , including sharing expertise, ensuring optimum decision-making, ... close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations . The Associate Director is also… more
- Merck & Co. (Rahway, NJ)
- …pr ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie ... supporting all protocol and program cost estimates requested by Product Development Teams . - Responsible for...processes and systems. - Stay updated on industry trends, regulations , and best practices related to clinical supply planning… more
- Merck & Co. (North Wales, PA)
- …research, pricing/ reimbursement, outcomes research or managed markets or business development .Knowledgeable about product development and commercialization ... global market access and pricing activities, including asset access strategy work, development of payer value proposition messages as well as payer value tools… more
- Merck & Co. (Rahway, NJ)
- …in data science, statistics, and a strong understanding of medical device and combination product regulations and processes.- It is expected that this role will ... or pharmaceutical industry.In-depth knowledge of medical device and combination product regulations , manufacturing processes, and quality control.Proficiency in… 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 ... up to date scientific information relevant to ensure personal development of the team; and between the field-based Medical...they and their team act in complete and total compliance with all laws, regulations and policies.… more
- Merck & Co. (Upper Gwynedd, PA)
- …and be accountable for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success ... together with risk mitigation measures.-Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of… more
- Merck & Co. (Rahway, NJ)
- …with United States and European Union GMP and Safety compliance regulations .Ability to convert new drug product attributes and process needs to ... Clinical Operations, Customer-Focused, Data-Driven Decision Making, Drug Product Development , Estimation and Planning, GMP Compliance , Management Process,… more
- Merck & Co. (Rahway, NJ)
- …, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development . This will involve handling of a variety of reagents, ... with the administration of cGMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development .Lean Six Sigma Training… more
- Merck & Co. (Durham, NC)
- …:-Achieve compliance goals through a risk-based approach (Safety Regulations , Quality Assurance, Risk Management, Deviation Management, Product Release, ... of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing development and… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend coverage will be ... operations;Ensure that Shift(s) objectives are achieved while reliably supplying quality product at a competitive cost consistent with our Company, Regulatory… more
- Lundbeck (Edmond, OK)
- …call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and… 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. The… more
- AUROBINDO (Durham, NC)
- …group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of ... training, on-boarding, orientation, policy implementation, compensation, and employment law compliance .Manage and conduct the new hire orientation and exit interview… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV… more
- Merck & Co. (Rahway, NJ)
- …in their HTA submissions.The Executive Director is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure ... Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Ophthalmology, Outcomes Research, Product Development Lifecycle, Social Collaboration, Stakeholder Relationship… more
- Merck & Co. (North Wales, PA)
- …in their HTA submissions. Incumbent is also expected to contribute to product development and marketing strategies throughout the lifecycle to ensure ... and meta-analyses, and economic modelling. Key responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for...that product value is defined and developed to achieve optimal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for each report based on position, skills, talents, and objectives Ensures compliance regulations are understood and adhered to consistently Recruit, build ... with multiple functions and groups throughout the US organization, Clinical development , Research & Early Development , other affiliates, and the… more
- Merck & Co. (Rahway, NJ)
- …, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development . This will involve handling of a variety of reagents, ... Familiarity with the administration of cGMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development . - Lean Six… more
- Genmab (NJ)
- …working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, HIPAA and other compliance regulations and guidelines relevant to industry interactions with healthcare ... to support both Genmab approved products and those in various phases of development . MSLs provide medical information through scientific exchange in a fair and… more
- Merck & Co. (North Wales, PA)
- …subsidiaries in their HTA submissions.The incumbent is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure ... and meta-analyses, and economic modelling. Key responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for...that product value is defined and developed to achieve optimal… more
