- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project...in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director , Quality Technical, is responsible for leading a team that supports deviation management, change control, site ... activities with department objectivesFUNCTIONAL EXPERTISE:Specific to Technical Support, the Associate Director will be responsible for comprehensive management… more
- Merck & Co. (North Wales, PA)
- …future?-We have an outstanding opportunity for an enterprising data and analytics technology leader who will thrive in a dynamic environment and one who is ... to the HH IT US Data Services Product Line Leader , this role will be responsible for the technical...data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as ... the global regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management ... centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior..., Enterprise Program Management, this position requires a capable leader with strong technology and business acumen who is… more
- Merck & Co. (Durham, NC)
- …while developing and expanding your career. - Position Description:- We are seeking an Associate Director within the Durham Operations team. The Associate ... objectives - Functional Expertise:- Specific to their area, the Associate Director will be responsible for comprehensive...and/or manufacture vaccine product to include the following: - Lead the team and others by providing direction and… more
- Merck & Co. (North Wales, PA)
- …for executing late-stage clinical trials across therapeutic areas around the globe.The Associate Director , Advanced Analytics will work with our partners across ... Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management ... operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training and Documentation management ... will take direction from global strategy and operational QA leader , however is also accountable to the VP of..., however is also accountable to the VP of quality . The incumbent is expected to understand and apply… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , Automation Th is position will primarily be responsible for ensuring reliability and efficiency of site ... data collection systems and other strategies that optimize statistical efficiency and quality - Develop and maintain Site Facility Energy Regression models - Work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs ... Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population...with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. ... labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... governance. Responsible for Strategic Application product roadmaps to meet business objectives. Lead the definition of solutions based on business needs, cost, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... policies and methodologies are understood and utilized. Serve as the lead "relationship manager" to proactively deliver strategic sourcing insights, optimal value… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... capture the full discussion for archiving. Serve as the primary contact with FDA. Lead and prepare FDA submissions, including but not limited to briefing documents,… more
- Novo Nordisk Inc. (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... development and scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel strategies towards… more
- Insmed Incorporated (Louisville, KY)
- …Patient Support Program and the reason we are seeking top talent for the role of Associate Director of Case Management. Patients are the core of what we do here ... on patient-centric initiatives? Do you want the opportunity to lead and collaborate with cross-functional stakeholders? If so, we...so, we want to hear from you! As an Associate Director of Case Management, you will… more
- Eisai, Inc (Nutley, NJ)
- …platform hardware/software, and networks). Essential Functions Strategy and Business Alignment 45% Lead the definition and design of high value solutions which align ... stakeholders including systems integration best practice and process excellence principles. Lead the definition of future state solution architecture by establishing… more
