- Merck & Co. (Rahway, NJ)
- …the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. They will be responsible ... clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head...Quality Assurance (QA) and acting as the link between Clinical Development , study teams, global business functions… more
- Merck & Co. (Rahway, NJ)
- …of matter manufacturing, testing, quality and supply processes from late clinical development through commercialization and uses this understanding to ... momentum, and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug… more
- Merck & Co. (North Wales, PA)
- …Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development , design transfer qualification and post marketing ... input/output requirements, including but not limited to chemical, physical, or performance specifications. Lead and manage development of Global Design file (GDF)… more
- Merck & Co. (Rahway, NJ)
- …, the Senior Clinical Director will manage the entire cycle of clinical development , including determination of appropriate disease indications to pursue and ... and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.Providing clinical… more
- Merck & Co. (North Wales, PA)
- …Working with the Asset Development Team (ADT's), early- & late-stage clinical development teams, the Biomarker (BMx) leads will develop asset-specific ... biomarker strategy by incorporating critical insight from discovery biology, clinical development , diagnostics, bioinformatics, molecular assay experts,… more
- Merck & Co. (Rahway, NJ)
- …depth and breadth of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance ... Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during… more
- Merck & Co. (North Wales, PA)
- Job Description- Role Summary:The Process and Systems Lead Senior Director, Medical Operations ( Lead , P&S) is a leadership role within Global Medical and Value ... (GMSA) that reports directly to the Executive Director (ED) Global Medical Operations Lead .-The Lead , P&S is responsible for managing people and building optimal… more
- Merck & Co. (North Wales, PA)
- …Vaccines Portfolio Marmeting Team, Integrated Account Management , Learning and Development , Clinical Review Teams, Legal and Compliance. In addition, ... with brand teams to understand priorities and synergies with commercial engagement.- Lead the development of resources through the promotional approval… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Principal Scientist - Device Development Lead (Director Equivalent) Our company's Device Development (DD) Team designs, ... with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Merck & Co. (Rahway, NJ)
- …vendors.Drive and influence the technology and innovation strategic roadmap for the clinical end to end data flow in partnership with functional stakeholders, ... capture appropriate KPIs.Provide leadership and subject matter expertise to the clinical platform by enabling new capabilities of the assigned business area.Become… more
- Merck & Co. (Rahway, NJ)
- …execution requirements for the deal.Performs all responsibilities of the GRACS Business Development Execution Lead (or Integration Lead for ... minimal guidance of the Senior Director or Director, Business Development Execution, the primary function includes coordinating various GRACS functional… more
- Merck & Co. (Rahway, NJ)
- …potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work… more
- Merck & Co. (Rahway, NJ)
- …potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work… more
- Merck & Co. (Boston, MA)
- …Dose Day.Establish and own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development ). Lead key technical reviews for Immunology ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development .-The AVP provides strategic oversight for the early… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development .- The AVP provides strategic oversight for the early ... direction of clinical programs involving translational research and early clinical development for the Cardiovascular & Respiratory Therapeutic Area.- They… more
- Aequor (NJ)
- … clinical demand changes. Developing supply forecasts through evaluation of the clinical development plan and protocol analysis. Reviewing and providing input ... 100 % remote Manager prefers local candidates (will consider non...of clinical supplies required to support global clinical research and development studies during phases… more
- Merck & Co. (Rahway, NJ)
- …potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work… more
- Merck & Co. (Rahway, NJ)
- …all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact ... for meetings with FDA at any phase of drug development . Lead cross-functional efforts to prepare for... experienceM.D. with minimum of 3 years relevant drug development experience or clinical experiencePhD/PharmD with minimum… more
- Merck & Co. (Rahway, NJ)
- …teams who are preparing for manufacturing drug substance to supply material for both development work and clinical studies in our kg scale (Prep Lab) and ... The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in… more
- Merck & Co. (North Wales, PA)
- …understanding of team and project leadership responsibilities. Applies knowledge of clinical development , relevant regulations, disease areas, and company ... is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer:… more
