- Merck & Co. (North Wales, PA)
- …will be an integral part of our company's efforts to ensure compliance with federal anti-kickback regulations.The FMV Sr. Specialist will lead, organize and ... and reviewing all data obtained for analysis from our preferred external consulting partner along with working directly with Finance, Legal and Compliance to… more
- Merck & Co. (Ames, IA)
- Job Description Responsibilities: The key responsibilities of the Senior Specialist can be divided in the 3 elements:Site Production PlanningIn coordination with ... including timely resolution, communication, and mitigation of future potential problems. Partner with production and support areas to critically analyze and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the SDTM deliverables for analysis and ... success in the assurance of deliverable quality and process compliance .Familiarity with statistical and clinical data management conceptsPreferred Experience and… more
- Merck & Co. (Rahway, NJ)
- …Corporate Audit and Assurance Services' (MCAAS) provides value-added independent and risk based audit, assurance and advisory services.Position Overview Function and ... the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior Specialist will:Participate in the execution of IT internal audit engagements.Support… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… more
- Catalent (San Diego, CA)
- Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... facility. As a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance,… more
- Merck & Co. (Durham, NC)
- …department within the site is seeking a highly motivated individual for a Senior Calibration Technician position. This individual will partner with Maintenance ... maintenance, and engineering support for the manufacturing in Durham, NC. The Senior Calibration Technician is recognized as a knowledgeable resource in maintenance,… more
- Merck & Co. (Rahway, NJ)
- …innovative thinking, state-of-the-art facilities, and robust scientific methodology, we partner to deliver the next medical breakthrough.Biologics Process Research & ... engineers to advance the biologics pipeline from early- to late-stage development. Partner with groups in both research and manufacturing divisionsRepresent your… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based ... in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the… more
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality.Strategic thinking - ability to turn strategy ... Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting processes (SOPs) and software development… more
- Insmed Incorporated (Bridgewater, NJ)
- …to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.ResponsibilitiesAdditional representative ... activities, as necessary.Participates and helps maintain study operations planning, risk assessment and mitigation strategies, and reviews and helps...of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study… more
- Merck & Co. (Rahway, NJ)
- …engagement, and stakeholder management, you will collaborate with cross-functional teams, senior stakeholders and our supplier network. You will lead the category ... adapt and scale our program in a dynamic environment.Job Description:Our sourcing teams partner with the business to ensure the efficient acquisition of goods and… more
- Eisai, Inc (Nutley, NJ)
- …from you. Position Summary: The Global Data Foundations CoE Lead (GDFCL) role is a senior role within the Global Data & Analytics IT team, reporting to the Global ... and global functions to harmonize Roles & Skills and partner with the Global Data & Analytics Technology Lead...the health of the program and take responsibility for risk management and course corrections as needed.Responsible for establishing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management: Assessing and ... US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution and spend of… more
- Merck & Co. (Rahway, NJ)
- …includes operating model, culture, talent development, technology introduction, and compliance .- However, one co-lead remains focused on non-sterile pipeline ... management processes that govern operations, including tier, clinical siting and compliance councils. Key performance indicators range from quality and regulatory … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate ... to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect with expertise in biopharma research to support our… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director/ Senior Director, the Principal Scientist /Director is responsible for developing and implementing ... including assessment of the probability of regulatory success together with risk mitigation measures.Lead the development, communication, and review of the CMC… more
- Merck & Co. (Rahway, NJ)
- …development and early adoption of novel process technologiesContribute to strategic initiatives; partner with senior leaders to set overall project strategy, and ... actively share expertise; guide career development; build strong, collaborative teamsChampion compliance and safety; promote a culture of diversity, inclusion, and… more
- Insmed Incorporated (Bridgewater, NJ)
- …the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance ... not necessarily be limited to, the following:Facilitate and maintain a risk -based and scientific-based quality system to support Good Pharmacovigilance Practice… more
- Highmark Health (Parkersburg, WV)
- …representation of the company. **ESSENTIAL RESPONSIBILITIES** + Matrixed working relationship with Risk Operations and Strategic Risk Partner to define ... capacity, the incumbent is responsible for the collaborative and iterative development of the risk and compliance plan for these entities across all areas in the… more
