- 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
- 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
- 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)
- …is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision ... a team of crystallization subject matter experts, the Crystallization Lab Lead collaborates with cross-functional teams to ensure small molecule Active… more
- Merck & Co. (Rahway, NJ)
- …providing operational and implementation of brand strategies. This individual will lead and manage all brand messaging, internal and external communications ... including all marketing, advertising, product pricing and related trade and industry programs. He/she...R&D and regulatory teams to ensure existing and new product development in the bios category is properly aligned… 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)
- …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)
- …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
- 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
- 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in ... project management office to enable robust production, testing and release of product to patients.Key Responsibilities Helps to develop and support implementation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management.Responsibilities- Lead drafting and negotiating contracts for ... to, areas of GPO/PBM and trade/distribution agreements, Medicare, Medicaid, product pricing, and government price reporting. Coordination with, and appropriate… 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)
- Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization and join the leadership team of Small Molecule ... organization is responsible for three core areas within SM S&T: (1) technical product leadership across the lifecycle of product franchises, (2) project and… more
- Merck & Co. (Rahway, NJ)
- …internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working ... program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie… 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
- 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
