- 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
- 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
- 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
- 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)
- …customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical… more
- Merck & Co. (Rahway, NJ)
- … Lead technical investigations of medical device and combination product needs for commercial products- Facilitate technology transfer of medical device ... Job Description Summary, Focus and Purpose The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team, with… 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
- Merck & Co. (Rahway, NJ)
- …value and enabling fact-based decision making throughout the lifecycle of the product . This role will be responsible to support brands with go-to-market strategies ... and internal clients such as marketing brand leaders, center of excellence teams, senior management etc., to stay abreast of business trends, understand the business… more
- Merck & Co. (Rahway, NJ)
- …position available at our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to ... define group strategy and to lead a team of scientists in solving complex analytical...testing of clinical trial material and in support of product and process development.A strong team player with excellent… 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)
- …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
- 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)
- …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
- 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
- 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
- Lundbeck (New York, NY)
- …and promotion of Lundbeck products in a distinct geographical region. The product portfolio currently includes both medical benefit and specialty distribution for ... team. Responsible for additional home office responsibilities assigned by senior management. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited Bachelor of… more
- 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
- 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
- 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
