- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible ... 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)
- …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)
- …efficiency and decision making.Responsibilities: Project ResponsibilitiesIndependently manage or lead strategy development for high complexity drug development ... the Global Team Leader to drive strategy development and create an integrated product development plan and timelines. Ensure execution of overall plan and annual… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Senior Product Manager, Key Customer Strategy will shape, implement, and execute ... the overall brand vision set by Genmab organizational leadership. Lead BsAb operationalization tactical execution, including tailored stakeholder engagement… 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)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development Team ... regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead /support/oversee clinical supplies production… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... lives for a living. Are you ready to make a difference? The Position Senior , Clinical Informatics leads the functions in the Clinical Data Science & Evidence (CDSE)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technology solution providers. Relationships This position will report to the Senior Director, Procurement Operations, Digitalization and BI Lead , and ... with Procurement technology solution providers. Essential Functions Partner with Senior Director to develop NNI Procurement's digitalization vision, strategy, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:Case review/approval for assigned ... external stakeholders (eg, Competent Authorities) for products for which the Senior Specialist is responsiblePV Statement preparation in compliance with relevant… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we embark on shaping our future. The Position The Hemophilia TA Lead is instrumental in shaping and executing NNI's strategic direction and initiatives within ... leaders. Incumbent oversees cross-functional teams to identify, develop and implement successful product plan. Helps to shape strategy and culture within their team.… more
- Merck & Co. (Rahway, NJ)
- …introduction(s) and commercial market(s) approval(s).Define design input(s)/ output(s) and lead associated combination product design verification plan, ... studies at the device component/ subassembly/ in-process material and combination product level. Lead stablishing test methodologies/ testing readiness and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... Organizations and Site Management Organizations etc.) Establish and manage senior level relationships positively with multiple internal stakeholders relevant 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
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionAs a Senior Software Engineer you will be a major contributor to the tech future ... integrations, and everything in between. You will be an integral voice in product development and execution, leading the creation of innovative and solid software to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …investigators, key opinion leaders, consultants, and key customer groups. Essential Functions Lead US input to overall product development Collaborate iwth NNI ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...a difference? The Position The Strategy Director is a senior individual contributor role, and the job function requires… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …their designated Hemoglobinopathiesa Therapy Area and for relevant in-line and new product commercialization assets (3 years prior to launch). They will lead ... functions that drive success. They will be empowered to make strategic decisions and lead the development and roll-out of tactics that pull through the strategy and… 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
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting ... role supports CMC development activities, including specification development, manufacturing, product release, stability programs, change management, and vendor oversight.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …achievement of Company and/or departmental expectations and goals as identified by senior management.ResponsibilitiesActs as a brand attorney and lead legal ... 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
