- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic and tactical leadership, and alignment to ways of working on assets which are subject to an Alliance. This role will work on one of our cutting-edge assets ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Genmab (Plainsboro, NJ)
- …of all documents and dossiers as applicable Proactively guide cross-functional teams as a subject matter expert to support submission strategyFor US based ... is a hybrid position based in our Princeton, NJ office , and can work remotely 40% of the time....time. You will report to the Global Regulatory Strategy Team Lead .ResponsibilitiesThe responsibilities of the role will… more
- Genmab (Plainsboro, NJ)
- …Affairs and other cross-functional teams.Patriciate in discussions as US Medical Affairs strategy subject matter expert in both internal and external venues ... requires weekly onsite presence in Princeton, NJ.ResponsibilitiesPartners with the indication strategy team lead to delivering the US Medical Affairs strategic… more
- Merck & Co. (Rahway, NJ)
- …employees can thrive. Responsibilities include but are not limited to: Act as a subject matter expert in process development and characterization of ... Expression Technologies (CET) group is seeking a Director to lead a microbial fermentation operation team to... members. Partner with functional area project teams and subject matter experts to establish and implement… more
- Aequor (Oceanside, CA)
- …and Eval Subject Matter Experts. Act as Site Operations Document Subject Matter Expert . Train others across the organization on document control ... training strategy, tech transfer readiness, and adhere to GMP regulatory requirements. Lead document revision teams and work streams, as necessary. Collaborate with… more
- Merck & Co. (South San Francisco, CA)
- …and/or new modalities.- Lead cross-functional scientific due diligence teams. Integrate internal subject matter expert input to build strategic rationale ... to bring new and life-changing therapies to waiting patients.- The Pacific BD&L team , which operates out of our Company's state-of-the-art R&D site in South San… more
- Merck & Co. (Rahway, NJ)
- …and management Primary Responsibilities: Serve as the subject matter expert in cell line development and technical lead to represent functional area ... and relevant sessions of IND and BLA filing.manage a team of 4-5 scientists, mentoring and guiding team...Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a… more
- Merck & Co. (Rahway, NJ)
- …of clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. - ... external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development...Mentors new team members and supports staff development, as needed Demonstrates… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …laboratory equipment and supplies. Additional duties may include acting as an internal subject matter expert and limited scope client interaction to ... to work independently and as a part of a team . Must have the ability to lead ,...staff and students. Must have working knowledge of Microsoft Office , as well as the ability to learn department-specific… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with project objectives Act as system administrator for the BMS system and act as subject matter expert regarding technical issues Support and develop and ... firm in an automation role is desired Demonstrated experience working in a team -oriented environment Experience and skills to lead and manage multiple complex… more
