- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by senior management.Responsibilities- Acts as a brand attorney and lead legal advisor for the commercial business and operations supporting US approved ... Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and...current developments in several key legal areas and provides Senior Management and other business leaders with updates regarding… 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product ... uphold the highest quality standards and drive innovation in product stewardship.- As a key senior member...Lead and provide strategic vision to the technical product stewardship department, overseeing technical support and product… 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)
- …to save and improve lives. IT Strategy Realization's (ITSR's) purpose is to lead value-driven outcomes and accelerate how we transform IT. Business of IT (BIT) ... and portfolio management, finance, resource planning and IT master data management.The Senior Specialist of Demand and Capacity Management Customer Success plays a… more
- Merck & Co. (Rahway, NJ)
- …manage clinical development projects; and assist the Associate Vice-President/Vice-President and product development team lead in ensuring that appropriate ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary...in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of… 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)
- …development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant as needed. The position ... to an executable series of steps and procedures to enable acceptable product manufacture. Familiarity with the administration of cGMPs, Good Documentation Practices… 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
- 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
- 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)
- …& 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
- Tris Pharma (Monmouth Junction, NJ)
- …in the pharmaceutical or biotechnology industry (including minimum 2 years as a Senior Product Manager or equivalent) in positions of increasing strategic and ... to hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior … more
- Bayer (Whippany, NJ)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Senior Product Lead ** Data-Driven R&D is at the core of Bayer's ... Pharmaceutical R&D venture. As a Senior Product Lead with Bayer, you will drive the digital transformation of R&D by translating our R&D strategy into value… more
