- 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
- Merck & Co. (North Wales, PA)
- …IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Cross-Functional Teamwork, Global Regulatory Submissions, Management Process, People ... 2025 ( ie IDMP related activities and submissions to Global Health Authorities ) . Th is will result...will result in positioning the Company competitively by streamlining product lifecycle management and helping to accelerat e time-to-market.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the implementation of a quality strategy ... of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality Reviews of respective product profile to ensure… more
- Merck & Co. (Rahway, NJ)
- …and final approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the ... approval by regulatory agencies for multiple indications simultaneouslyProvide expert advice as the Global Regulatory Lead to Product Development Teams and… more
- Merck & Co. (Rahway, NJ)
- …of the Sr Principal Scientist Patient-Centered Endpoints & Strategy (PaCES) lead , the Senior Scientist has responsibility for coordinating global ... analysis and interpretation of COA endpoints to support overall product development. The Senior Scientist will work...Senior Scientist will work closely with the PaCES lead to collaborate with individuals from Clinical Research, Regulatory… more
- Aequor (Thousand Oaks, CA)
- …seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Act as MSRT product lead and/or therapeutic area lead Execute ICSR case ... medical review Conduct reportability assessment for medical device associated events and/or product complaint associated events, and review for potential product … more
- Novo Nordisk Inc. (Boulder, CO)
- …process Management of outsourced inventory (Raw Materials, Drug Substance, Drug Product ) Lead continuous improvement activities at outsourced CMOs Review ... develop new medicines for patients. The Position The Specialist, Logistics & Global Trade Compliance is responsible for enforcing company-wide compliance with US… 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 Solution Architect plays a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including...provide input for the vision and direction of AI product deployment and governance to ensure responsible and efficient… more
- Merck & Co. (Durham, NC)
- …in response to evolving global demand dynamicsEngage in resolution of global product supply disruptions where long-term strategic supply chain alternatives ... Management (VCM) is the accountable organization for our company's Manufacturing Division product supply chain strategy in alignment with Global Human Health… more
- Eisai, Inc (Nutley, NJ)
- …Directs and manages a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development, as well as ... regulatory representative on the project team throughout the product lifecycle. Provide senior staff advice and...timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives… more
- Aequor (Thousand Oaks, CA)
- …will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution control. May also translate ... - PST preferred Ideal candidate - 3-5 YOE, lifecycle management knowledge of full product manufacturing stages experience. The Supply Chain Project Manager (SCPM)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... SummaryThe Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety...across various regions, offering guidance and support to each product safety team in critical areas such as individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization ... and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development… more
- Repligen (CA)
- …the product portfolio for each Account ManagerDevelop and grow global key account relationshipsAnalyze and report progress on sales revenue to forecastMaintain ... OverviewWe are seeking a seasoned Senior Director, Sales whose primary role is the...Headquarters in Waltham, Massachusetts, this role reports to the Global Head of Sales.This role is ideal for an… more
- Merck & Co. (North Wales, PA)
- …solutions, thereby driving our organization's growth and success.Key responsibilities include:Influence global and regional business leadership and product line ... (BTP), you will report to the Development IT BTP lead within our company's Research Laboratory IT. You will...business value. This role will initially focus on the Global Clinical Trial Operations (GCTO) functional area, with the… more
- Merck & Co. (Rahway, NJ)
- …robust solutions and approaches are developed by working teams supporting the product .Compile with our company's Global and regulatory requirements and execute ... CMC development and commercialization strategy which yields the target commercial product .-The specific role will be responsible for advancing the company's Antibody… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the… more
- Novo Nordisk Inc. (WA)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... and globally. Relationships Reports to the Market Access and Public Affairs Senior Director, Policy. Other internal relationships include a dotted line with… more
- Merck & Co. (Durham, NC)
- …Manufacturing Operations will also assist in commercialization activities for New Product Introductions that require complex devices and other novel technologies. ... Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply:… more