- Merck & Co. (Boston, MA)
- …Division's disease areas, as well as participate in relationship management of Contract Research Organizations (CRO).- The ideal candidate will be a skilled ... scientist and team player with experience supporti ng collaboration s across a broad range of departments and disciplines. In collaboration with Quantitative Biosciences (QB), this individual will effectively assess and grow our Research and Development… more
- Lundbeck (Bothell, WA)
- …organizations (CMOs) Collaborate with QC to ensure successful method validation at contract labs/CMOs; support investigations and lead troubleshooting efforts as ... is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development of...to establish and qualify GMP analytical cell banks at contract labs (suitable for use in GMP testing) Oversee… more
- Eisai, Inc (NJ)
- …from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the outsourcing of clinical services to ... teams on vendor selection and management options in alignment with global strategies. Lead the process of Request for Proposal (RFP) development through supplier… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path ... for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical Study Oversight Plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical ... and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross functional Clinical Study Oversight… more
- Merck & Co. (Rahway, NJ)
- …members upon completion of the due diligence and understanding of the contract execution requirements for the deal.Performs all responsibilities of the GRACS ... Business Development Execution Lead (or Integration Lead for Acquisitions/Mergers/Collaborations or Transition lead for Divestitures) including facilitation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, with management of SDEA requirements, ... on all case processing and compliance reporting processes and take lead role in the audit/inspection process (eg, prepare pre-audit requests, perform… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead innovation, coordination, and strategic planning efforts and will be responsible to ... Proactively identify area of future improvement foreseeable future solutions, foster, and lead strategic thinking workshops or work meetings for Leadership Team, to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processing, and reporting of diverse external data across DS Programs.Participates in Contract /SOW reviews and MSA discussions of External Vendors by engaging with ... with agreed upon EFTs, eDTS, DS External Data Standards and Contract /SOW.Promotes Daiichi Sankyo values and quality workplace culture, collaboration in… more
- Merck & Co. (Rahway, NJ)
- …for drug/vaccine projects.-This position may serve as a statistical lead in project teams.Responsible for supporting scientific projects or protocols.Independently ... national standards committees.- Primary activities: Serves as statistical representative and lead in the cross-functional teams for the strategic planning and… more
- Catalent (Manassas, VA)
- …services, and capital for the site. The Site Procurement Manager will lead site procurement team and initiate and foster relationships with site stakeholders, ... for inventory build, and proper escalation. Increase spend under contract . Negotiates supply agreements with vendors improving commercial conditions.Responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …For studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):- Provides oversight to the CRO ... needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to ... that could impact the company and patients. Informed by collaboration across functions, lead efforts to develop strategies to mitigate risks and harms while also… more
- Merck & Co. (Durham, NC)
- …seeking to hire an experienced and technically proficient people manager to lead a team of coaches, production specialists, and operators through commercial ... manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team and be accountable for all human resource activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... growth and provide development opportunity for statistical programmers. Manages contract statistical programming staff to ensure proper resource allocation for… more
- Insmed Incorporated (Bridgewater, NJ)
- …of nonclinical safety data; and oversee nonclinical safety studies outsourced to contract research organizations. Provide strategic input to project teams and senior ... years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the pharmaceutical or biotechnology industry or within a regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and monitors vendor activities (translations) including, but not limited to contract negotiations and other SOW maintenancePartners with RD Procurement to ensure ... and - Prior work experience as a project manager, project lead , or similar role within pharmaceutical drug development desirablepreferred TravelAbility to… more
- Merck & Co. (Durham, NC)
- …by obtaining bids, review contracts, supervises work execution, and follows-up on contract work including the auditing of time and material reportsOversee and ... to manage multiple priorities and advance several tasks in parallel and lead to completion.Leads others in seeking out ideas and information to improve… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational efficiency, and deliver exceptional meeting experiences.Vendor Relations and Contract Management - Develop and nurture relationships with vendors and ... of technology solutions and identify and implement areas for enhancement.- Lead or contribute to process improvement initiatives, streamlining workflows, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Procedure (SOP) (regional review, Global review, tracking of milestones as per contract ). Ensure the global clinical operations systems for management of company ... on key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality.Establish strong partnership with Functional… more
