- Novo Nordisk Inc. (San Antonio, TX)
- …strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North… more
- Merck & Co. (Rahway, NJ)
- …within the pharmaceutical or a related industry (hospital, public health, etc.) Strong project management skills and the ability to juggle multiple tasks and ... to take center stage around the globe, timely completion of carefully designed clinical trials is critical to drug development.The Associate Director, … more
- Merck & Co. (North Wales, PA)
- …knowledge of- statistical and data processing software eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements ... and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical ... an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (North Wales, PA)
- …and translation vendors.Support implementation of COA measures in connection with our company clinical trials through strong project management and timely ... clinical outcome assessment licensing and translations agreement negotiationProject management experience and/or certificationGood Clinical Practice certification/training#EligibleforERP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position requires skills in working in a fast-paced environment, continuous improvement, project management , change and risk management . Responsibilities - ... builds and maintains positive relationships with internal/external stakeholders/vendors/partners. - Project Management : Is accountable for quality of delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies. Partner with Project Management , Clinical Operations and other ... process. Coordination with all functional areas impacted including Legal, Procurement, Project Management and Commercial or Corporate Finance, Operations.… more
- Merck & Co. (Rahway, NJ)
- …of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product. Additionally, experience in medical ... objectives utilizing external contractors including GMP qualification as well as site/ project selection.- Additionally, the incumbent would serve as the bridge… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …with in vivo CAR-T and preclinical studies. Excellent leadership, communication, and project management skills. #LI-RT #LI-OnsiteLegend Biotech is a proud equal ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based… more
- Merck & Co. (North Wales, PA)
- …the leadership level including the development of electronic submission deliverables.Strong project management skills; A program leader; Determines appropriate ... systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine… more
- Merck & Co. (Rahway, NJ)
- …Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder Relationship ManagementPreferred ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research ... facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked...of release, characterization, and stability assays for testing of clinical trial material and in support of product and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and inspections. Finally, this position has strong skills in continuous improvement, project management , change management , and risk management ... for a larger number of projects/studies with greater complexity.May manage Data Management full-time and/or contract staff. Project Management :Plans and… more
- Merck & Co. (Rahway, NJ)
- …and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management , and organizational skillsWilling to travelAble to ... process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical and… more
- Merck & Co. (North Wales, PA)
- …industry experience.Required Experience & Skills: At least 3 years project management experience at or supporting -pharmaceutical/biotech companies ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central...and keep team members, departmental colleagues (as appropriate) and management fully apprised of project / initiative… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …effectively interfaces within a matrixed environment and with varying professional levels Leads Clinical Ancillary Management project teams to ensure ... designing and implementing innovation/improvement initiatives, including the required change management Project Management experience including demonstrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …have demonstrated ability to formally plan, execute, and deliver projectsMust have Project Management experience Licenses and CertificationsIf degree is outside ... and expertise. Finally, this position makes tactical decisions utilizing input from upper management that impacts more than one project team at a time.… more
- Merck & Co. (North Wales, PA)
- …reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines ... be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM… more
