- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as needed and ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Merck & Co. (Rahway, NJ)
- …scientists with a focus on drug substance (API) analytical deliverables to drive lead -time reduction and efficiency gains in support of our company's World Class ... Supplier and Operationalizing Quality goals.- The Senior Scientist position is a laboratory-based scientific track role in a fast-paced, multidisciplinary team… more
- Merck & Co. (Rahway, NJ)
- …closely with PMO Leads, technical leads, software engineers, architecture team, product managers, vendors, other technical project managers, and business functional ... set and pre-work for workshops is prepared and effectively lead discussions to ensure groups don't lose focus on...and Skills: -PMP or equivalent or Scrum Master or Product Owner certificationPrior experience in the pharmaceutical industry or… more
- Merck & Co. (New York, NY)
- …background and a growth mindset to join our team. As the Regional Cardiovascular Lead (RCL), you will have a key role in shaping and supporting the transformation ... limited to: Scientific and Clinical Leaders Engagement: Serve as a disease, product and cardiovascular resource while engaging with select scientific and clinical… more
- Merck & Co. (Rahway, NJ)
- …Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This position will be a ... member of the Research Automation Operations product (Laboratory and Plant) within RIPL. -As Sr. OT...within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles… more
- Merck & Co. (Rahway, NJ)
- …Utilities and Validation. We are seeking a Growth and Improvement minded Senior Scientist, Engineering that can help drive our Strategic Operating Priorities.Invent ... responsibility, mentoring, and leadership of internal and external work. This Senior Scientist, Engineering position leverages significant depth and breadth of… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development (SMARD) is seeking a highly motivated Senior Scientist -Microbiologist to join the growing Microbiology Center of Excellence ... all in a GMP environmentKnowledge and experience with manufacturing and product testingExperience in leading and supporting quality investigations and change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical ... areas regarding clinical issues related to oncology compounds.-The Executive Director/PDT lead may:-Manage Directors and/or Senior Directors responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead /support/oversee clinical supplies production ... respect to device component manufacture and final assembly of biologic/drug product with device constituent part. Lead /support the development, implementation and… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... collaboration skills.-A strong track record of publications in parenteral drug product development and/or deliveryDemonstrated ability to lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …that will inform investment decisions. The Portfolio Manager reports to the Value Team Portfolio Lead and works closely with Product Line Leads , Product ... of Ownership (TCO) & value realization that supports decision making for Portfolio Lead and Value Team.-Independent content creation for Senior Leaders that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... Global Team leader as the Project Management lead on drug development projects. This position can be...strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to… more
- Merck & Co. (Rahway, NJ)
- …& Respiratory Therapeutic Area (CV&R). The incumbent will be expected to lead multiple programs including those new to the organization therefore requiring someone ... who has built and lead clinical development plans from the ground up. They...ground up. They will also be responsible for guiding Product Development Team Leaders and Clinical Directors within their… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk management activities for his/her portfolio. Serves as the company's senior representative with key high-level internal and external stakeholders on important ... drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk management activities. Providing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and summarize conclusions and recommendations for discussion with and presentation to senior management. Schedule and lead diligence meetings with potential ... disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the...support more complex projects, including those to acquire new product opportunities or technologies to augment our pipeline. This… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting hypothesis-based assessment… more
- Merck & Co. (Rahway, NJ)
- …and assessment of emerging drug delivery device technologies. The ideal candidate will lead efforts in assessing the viability of new concepts and drive early ... intellectual property (IP) considerations in collaboration with the Legal department. Lead early feasibility/development studies to determine viability and inform on… more
- Merck & Co. (Rahway, NJ)
- …development projectsAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate ... corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.The Clinical Director is responsible for maintaining a… more
