- Merck (Rahway, NJ)
- …Dynamics, Metabolism and Bioanalytics (PDMB) is seeking a Senior Director to lead the regulated vaccine assay outsourcing (OS) team. The OS function within ... for the oversight of contract research organization (CRO) regulated preclinical/ clinical assay method development, qualification/validation, and testing in support… more
- Bristol Myers Squibb (Princeton, NJ)
- …plan, and application to the Scientific Communication Platform (SCP). + Lead development of medical communications and ensure timely journal submissions, ... aligned medical communications plans; adjust communications plans in accordance with clinical trial results/milestones and changes in the healthcare landscape +… more
- Fujifilm (Trenton, NJ)
- …requirements of the portfolio(s). + Develop product evaluation protocol for new products and lead the evaluation on- site . (ie managing the site selection ... in the marketplace. Activities include delivering various presentations, conducting site -visits, attending shows and conferences, inquiry handling, etc. Partner with… more
- Merck (Trenton, NJ)
- …study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and ... policies. + Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the RMSD's… more
- Bristol Myers Squibb (Princeton, NJ)
- …(GLP, CLIA, CAP, ISO13485, 21 CFR Part 11, QMSR, IVDR). You will lead project coordination for clinical bioanalytical studies, including oversight of critical ... and internal cross-functional teams. **KEY RESPONSIBILITIES** **Project Operations** + Lead and coordinate regulated bioanalytical and CDx studies, including CRO… more
- Bristol Myers Squibb (Summit, NJ)
- …local, state, federal regulations (eg, OSHA, EPA, ISO, cGMP). + Serve as the site lead for EHS data management systems, ensuring accuracy and timely reporting ... Manager with a strong background in the pharmaceutical or life sciences industries to lead and enhance our site -wide S&OH programs. The ideal candidate will be… more
- Merck (Rahway, NJ)
- …DSCS Digital Implementation Project Manager** Within the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline ... execution and management of DSCS Digital initiatives. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development,… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. The PPD (TM) clinical research business of Thermo Fisher Scientific is a leading provider of ... and value realization for an end-to-end digital domain, specifically clinical trial execution, supporting and building new products that...the UK. Travel is estimated up to 25% for site visits, customer meetings, and team onboarding across Europe,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Proficient in GxP Auditing with a successful track record of leading clinical /investigator site audits. + Broad experience participating in cross-functional ... deliverables across large sites, countries, or multiple regions. + Lead internal and external R&D quality audits for assigned...GxP Auditing with a successful track record of leading clinical /investigator site audits. + Thorough knowledge of… more
- Bristol Myers Squibb (Summit, NJ)
- …the meeting of budgets for their WCT. **Meetings** + Is responsible to facilitate and lead weekly Tier meetings using the site standard Tier meeting tools. + ... as a Safety Change Agent supporting safety initiatives and requirements across the site and within WCT. **Documentation** + Is accountable for the Production Records… more