- 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
- Aequor (Thousand Oaks, CA)
- …as an integral member of Project Delivery teams Be the Contracting lead , leading contracting activities including selecting appropriate contract template, ... Plan with Project Manager as a \"living document\" throughout project life cycle Lead selection of Project Delivery approach, Contract Strategy and commercial… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Executive Director, US Market Access Contracting will lead and oversee teams responsible for the implementation of our contract strategies ... Forecasting, Payer/ Customer Master, Primary Care, Hospital, Specialty & Rare Disease Contract Planning & Analysis, Oncology Deal Modeling & Forecasting, Oncology … more
- Merck & Co. (Rahway, NJ)
- …partners especially in PR&D and Analytical R&D, as well as external Contract Research Organizations, Contract Manufacturing Organizations, and academic labs to ... significantly impact on multiple projects with demonstrated depth of knowledge Experienced co- lead or lead on cross-functional teams with demonstrated impact… 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
- Aequor (Thousand Oaks, CA)
- …Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide ... functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include: Author or oversee the authoring of… 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)
- …studies as well as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create ... initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process and provide input into ARO selection.Validate the… more
- Merck & Co. (Rahway, NJ)
- …for an experienced and motivated Finance Leader to partner with the business, lead and support key categories within AH Procurement in many aspects of supplier ... relationships such as: Vendor selection, contract negotiation & review, supplier risk assessments, savings calculations, financial controls, budgeting, forecasting,… more
- Merck & Co. (North Wales, PA)
- …patients and global human health. Responsibilities :Serves as a statistical lead in project teams.Develops, coordinates, and provides biostatistical leadership and ... clinical drug/vaccine projects.May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.The incumbent… more
- Merck & Co. (Durham, NC)
- …by leading the site Validation Center of Excellence.- The primary responsibility is to lead the team of validation Subject Matter Experts as part of the site ... during inspections and supporting responses as neededMaintaining an effective contract staffing model as neededDeveloping the next generation of validation… more
- Merck & Co. (Rahway, NJ)
- …that enable new SAP capabilities and technologies. As the Clinical Manufacturing Delivery Lead for our Research & Development Division , you will be responsible for ... with our company's' stakeholders to capture user requirements and process flows, lead and participate in design, and build solutions with business users and… more
- Merck & Co. (Rahway, NJ)
- …that enable new capabilities and technologies. As the Clinical Supply Delivery Lead for our research organization, you will be responsible for delivering SAP ... in interviews with our stakeholders to capture user requirements and process flows, lead and participate in design, and build solutions with business users and SAP… 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
- Insmed Incorporated (Bridgewater, NJ)
- …techniques in support of preclinical stage small molecule research projects. Lead activities related to analytical testing and method qualification, including ... accuracy, completeness, and validityInteract with internal partners, CROs and contract laboratories during the development of analytical methods, stability testing,… more
- Aequor (Thousand Oaks, CA)
- …PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and ... audits and responses to questions. The individual is directly responsible to lead a Product Quality Team (PQT), including oversight of the product stability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of concern and either resolve or bring to the attention of the Delivery Lead . Coordinate and liaise with Daiichi Sankyo QA on audit activitiesProvide oversight of ... company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Time spent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal ... strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision,… 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
