- Merck & Co. (Rahway, NJ)
- …with company requirements and regulations are delivered and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations ... Quality Management (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead ...Clinical Quality Managers (ACCQMs) as well as talent development in collaboration with RCQM. -The role requires the… more
- Merck & Co. (Rahway, NJ)
- …enable and drive alignment with the goals, purpose and-mission of our Research & Development Division , Global Clinical Development (GCD) and GCTO.Ability to ... Description: Clinical Research Manager (CRM) - General Medicine ( REMOTE ) This role is primarily accountable for the end-to-end performance and… more
- Merck & Co. (Rahway, NJ)
- …ideas and innovative solutions that enable new capabilities and technologies. As the Clinical Supply Delivery Lead for our research organization, you will be ... responsible for delivering SAP solutions to our Research Organizations' Global Clinical and Ancillary Supply-user community. You will p articipate in interviews with… more
- Merck & Co. (Rahway, NJ)
- …enable new SAP capabilities and technologies. As the Clinical Manufacturing Delivery Lead for our Research & Development Division , you will be responsible ... for delivering SAP solutions to our Global Clinical Manufacturing user community. You will p articipate in...company's' stakeholders to capture user requirements and process flows, lead and participate in design, and build solutions with… more
- Merck & Co. (Philadelphia, PA)
- …organization, strategic direction, and overall performance of the eSSC. Ensures sound clinical development principles are incorporated into the services provided ... verbal) communicationNegotiating and problem-solving skillsStrategic thinkingDemonstrated Knowledge of E2E clinical development processDemonstrated mentoring skillsAbility to establish… more
- Merck & Co. (Rahway, NJ)
- …in the role of-Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development ... inform dose selection and go/no-go decisionsBeing or supporting the QP2-I/O Function Lead on oncology development teams.Data management and analysis.On the job,… more
- Merck & Co. (North Wales, PA)
- …with squad members including but not limited to scrum masters, technical lead (s) and development team to manage high-quality product delivery leveraging ... Job DescriptionClinical Development heavily relies on accurate data collected from...accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections,… 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)
- …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)
- …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)
- …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)
- …labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other country's Local Labeling.- ... labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority- - Minimum education required: Bachelor's… more
- Merck & Co. (Rahway, NJ)
- …robust and scalable upstream processes for biologics in different stages of clinical development , 2) process characterization and regulatory filings for ... achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development , Analytical, Formulation, and Commercial Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …the- development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, ... In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include...This research opportunity is fast-paced and contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of… more
- Merck & Co. (Rahway, NJ)
- … trial.- May serve as the clinical trial team lead - May lead team in key study planning, development , and execution elements (eg, data management ... 5 years OR Master's + 3 years Pharmaceutical and/or clinical drug development experience OR PhD/PharmD Degree...by site or organization, with Friday designated as a remote -working day, unless business critical tasks require an on-site… 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
- Aequor (Thousand Oaks, CA)
- …include: ? Translate Toxicology, Pharmacokinetics and Drug Metabolism (PKDM) and Clinical Development study requirements into an actionable supply plan. ... Remote role - need to work Pacific zone...are understood. ? Serve as the primary interface with Clinical Development , Quality, Biostatistics, Regulatory Affairs, Corporate… 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
