- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality ... oversight across all Medical Affairs programs. This role involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will vary depending on the stage of development of assigned projects (ie, Phase I through commercialization).Responsibilities:Depending on the status of development ... of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.Effectively represent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college ... or university)PharmD An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is required required orPhD An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Audit: Support the completion of GMP audit and vendor qualification program creating audit plans, organizing audit schedule, monitoring the completion of proposed ... CAPA plans and managing metrics related with audits and vendor performance. Responsible to complete on paper basis audit and to monitor vendor performance management program. Support the issue and communication of audit plans, agenda and report to the vendors… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Support manufacturing activities for cGMP compliance through spot ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Merck & Co. (Rahway, NJ)
- …This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from ... early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role will also be responsible for leading and supporting continuous improvement initiatives related to design control and… more
- Merck & Co. (Rahway, NJ)
- …Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for ... our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for… more
- Merck & Co. (Rahway, NJ)
- …Job Description: The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance ... manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials.… more
- Merck & Co. (Rahway, NJ)
- …The Director of Commercial Strategy will lead and support strategy development for enterprise-critical commercial initiatives, assessing and designing priorities that ... are complex questions with significant upside for the company, but high ambiguity. This includes ongoing initiatives across our Company as well as the establishment of new strategies and capabilities. This role will work cross-functionally with senior leaders… more
- Merck & Co. (Rahway, NJ)
- …Provide leadership and strategic direction to ensure your team provides the highest level of customer operational efficiency and execution.Act as point person for ... Job DescriptionWe deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.- Within the Animal Health Division, we are seeking an Associate Director, Customer Operations, to provide strategic leadership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Education Level: Bachelor's degree in Finance, Economics, Mathematics, Data Analytics, Engineering, or similar Experience Level: 2 years Specific or technical job ... skills: Minimum 2 years of experience in driving digital transformation initiatives, process automation, data strategy implementation, data governance or similar Minimum 2 years of hands-on experience in Python, R, SQL or other software development Data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A Bachelor's degree required; relevant experience may be substituted for degree, when appropriate A minimum of 8 years relevant experience in the areas of pricing, ... contracting, forecasting, financial modelling, and payer landscape required. Pharmaceutical experience preferred Ability to manage multiple projects, collaborating with all stakeholders at all levels of the organization to analyze, develop and execute… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A Bachelor's Degree in Business or equivalent experience. MBA or another advanced degree preferred. Relevant experience may be substituted for degree, when ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions that drive patient access to innovative products. We strive to deliver the best possible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The purpose of this job is to work with DS internal teams to assess, help select vendors, negotiate and execute contracts. Performs financial reconciliation and ... negotiation of clinical R&D Vendor contracts prior to study termination and contract closure. Lead all aspects of sourcing and negotiating Vendor contracts to ensure that the contracts add value to the organization (cost, quality, timelines). Take ownership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Lead the development of blended training programs inclusive of advanced skills with clinical knowledge, account management, market landscape, and the Business of ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Merck & Co. (Rahway, NJ)
- …Assistant Production Lead - Early Development CenterLocation:-Rahway, New JerseyDepartment:-Pharmaceutical Operations and Clinical Supply-Position OverviewJoin us at ... the forefront of pharmaceutical innovation! The Formulation, Laboratory, & Experimentation Early Development Center (FLEx EDC) is a state-of-the-art Non-Sterile, predominately Oral Solid Dose (OSD), Drug Product development and GMP clinical manufacturing… more
- Merck & Co. (Rahway, NJ)
- …degree required.Required Skills/Abilities:Minimum 5 years sales experienceSpeak Up & Be OpenmindedExcellent interpersonal/communication and presentation ... skillsDemonstrated motivation and focus on achieving measurable, tangible results.Commitment to collaboration as the normal mode of working and resolving problems.Demonstrated understanding of positions' contribution to the business goals and willingness to… more
- Merck & Co. (Rahway, NJ)
- …Willing to learn and use the internal computing platform. Develop study design (DOE), statistical analysis, and reported output using in-house developed JMP tools in ... fast-paced, critical path projects. Provide expert second statistician review of drug substance process characterization studies. Participate on drug substance process characterization teams to understand requirements to design study experiments and discuss… more
- Merck & Co. (Rahway, NJ)
- …Lay out and fabricate threaded, flanged, pressed, brazed/soldered and swaged piping/tubing systems and associated equipment. Install, alter, maintain, repair and test ... piping systems of all types and materials. Work from sketches, P&IDs, isometrics or verbal instructions. Install, maintain troubleshoot and repair regulators, gauges, valves, traps, filters, safety valves, rupture discs and other equipment used or connected to… more
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