- Genmab (NJ)
- …of the external environment may impact their area of responsibility. People manager: Lead a small/ local team to ensure oversight of deliverables, development ... employees.Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe...to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by… more
- Merck & Co. (Rahway, NJ)
- …Development (AR&D) Associate Principal Scientist to serve as a Device Analytical Lead supporting medical device and combination product (MDCP) programs at various ... MDCP programs, serving as a key member of the Combination Product Analytical sub- team within the Combination Product Working Group. -The Device Analytical Lead … more
- Novo Nordisk Inc. (Boulder, CO)
- …of both worlds to develop new medicines for patients. The Position The Technical Team Lead , API Manufacturing works in Novo Nordisk's Boulder, Colorado Pilot ... to ensuring the supply of API and meeting production goals, the Technical Team Lead actively supports continuous improvement initiatives and identifies wherever… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight of the Oncology and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring ... designated programs.Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality… more
- Merck & Co. (Rahway, NJ)
- …associated services to advance the drug discovery and development pipeline. Our IT team operates as a business partner proposing ideas and innovative solutions ... PA, NJ, Boston/CambridgeThe Research and Development Sciences (RaDS) value team in R&D IT brings together product management, engineering,...data scientists to assess value risk , usability risk , feasibility risk and business … more
- Merck & Co. (Rahway, NJ)
- …Supply Chain Working Group (SCWG) for pipeline products or Value Chain Management Team (VCMT) for commercial productsSupport and/ or lead commercial siting ... technical changes, robustness/quality/ productivity projectsManage product supply chain Integrated Risk Management (IRM) and Business Continuity Planning (BCP),… more
- Merck & Co. (Durham, NC)
- …. Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant ... Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with… more
- Merck & Co. (Boston, MA)
- …associated services to advance the drug discovery and development pipeline. Our IT team operates as a business partner proposing ideas and innovative solutions ... DescriptionJob Description: The Research and Development Sciences (RaDS) value team in our Company R&D IT brings together product...data scientists to assess value risk , usability risk , feasibility risk and business … more
- Merck & Co. (Rahway, NJ)
- …Understand the big picture, and how activities link to our Company strategy and business goals- Utilize device risk management tools to build device or ... Technology is a key member of our Device Development & Technology Team , with responsibilities supporting the commercialization and sustainmentof medical devices and… more
- Merck & Co. (Rahway, NJ)
- …target commercial product.-Leads the cross-functional DCT, critically assessing all team deliverables & fostering a learning and collaborative environment. ... CMC and effectively communicates across the governance bodies, stakeholders, and team to drive outcomes/decisions through influence, advocacy, & negotiation with an… more
- Repligen (Waltham, MA)
- …employees to help navigate situations as they arise. Partner with our legal team on policy interpretation, investigations and risk mitigation. Provide data ... a strategic and experienced HR leader to establish and lead our North America Employee Relations Center of Excellence...the ER COE, this role will also provide HR Business Partner support for our Hopkinton, MA site. ResponsibilitiesDesign… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical ... immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy...targeted source document verification and targeted source data review. Lead the team to develop and implement… more
- Merck & Co. (Rahway, NJ)
- …as needed Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence ... between clinical development teams and the operational/executional arms within the business . The Program Clinical Supplies Project Manager (Program CSPM) serves as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …measurements and governance reviews are on track and align on major milestones and business reporting requirements. The role has a team of Launch excellence ... in the Cardiometabolic market landscape Dedicated Launch Analytics Hub: Lead and drive the team for creation...the brand/launch plan to brand and marketing leads. Uses business and launch expertise to inform risk … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions, offering guidance and ... support to each product safety team in critical areas such as individual case medical...in critical areas such as individual case medical review, risk management, aggregate safety reports, and translational medical safety.… more
- Formation Bio (New York, NY)
- …are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team ... are looking for a Senior Software Engineer, Applied AI to join our dynamic team at Formation Bio. As we continue to revolutionize the drug development process, this… more
- Aequor (Thousand Oaks, CA)
- … Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20. The NPI Lead is expected to have ownership ... Lead needs to be able to understand their business and manufacturing processes with enough confidence to drive...effective communication, both within and outside of the immediate team . The NPI Lead will be primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(PoC) for gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea etc.)For recruitment in ... as well as UK and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and… more
- Eisai, Inc (Raleigh, NC)
- …plans to meet the demand forecast. The Director, Western SCM Unit will lead a cross-functional team driving excellence in Import/Export Compliance, Logistics, ... plans to meet the demand forecast. The Director, Western SCM Unit will lead a cross-functional team driving excellence in Import/Export Compliance, Logistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and ... as well as overseeing functional service providers to achieve business objectives. It requires extensive knowledge of clinical data...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… more