- Merck & Co. (North Wales, PA)
- …Owner for one or more of the QMS processes managed under GRACS(Global Regulatory Affairs & Clinical Safety) Quality &Compliance.Establishes and maintains an ... a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge.-Applies capabilities to enhance quality and builds capabilities… more
- Insmed Incorporated (San Diego, CA)
- …MAA)Prior experience leading direct interactions with Health AuthoritiesPrior experience in regulatory leadership within gene therapy or orphan (rare) ... as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory … more
- Merck & Co. (Philadelphia, PA)
- …activities related to planning, execution, and management of delivery of high quality and timely regulatory submissions.The responsibilities of the incumbent may ... department, as appropriateParticipate in training courses to increase job role skills and regulatory knowledge Program : Support in the creation of FDA cover… more
- Merck & Co. (Rahway, NJ)
- …Technology (IT) Infrastructure, IS Audit, Life Science, Management Process, Project Leadership , Project Risk Assessments, Quality Assurance (QA), Quality ... Description: As a member of the Company's Research Laboratories Quality Assurance community, provide for and lead Quality...and maintain an overall computer system validation posture and program for a defined functional area(s) (single point of… more
- Aequor (Cincinnati, OH)
- …to: leading quality /food safety activities such as the plant sensory program , quality notifications, holds, allergen and organic inspections, sampling, food ... Job Title: Food - Quality Technician Location: Cincinnati, OH 45241 Duration: 03...for defective materials or packaging Lead the plant sensory program , documentation, and gold standard management Micro/allergen testing organization… more
- Eisai, Inc (Nutley, NJ)
- …and assess long-term resource, technology, and skill needs for respective program (s) within clinical quality area.Anticipate immediate and long-term risks ... industry-wide QA community, present, publish at conferences, journals on clinical quality topics.Build and manage overall relationships with regulatory bodies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA, the Director of Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. ... Affairs leaders to assign tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution, Health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management to ensure safety information is processed according to corporate timelines, quality and regulatory requirements Leads the safety follow-up process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This leader will also ensure a ... in place for each CRO to best support each program . This position will require line management responsibility of...will work closely with Directors, Study Teams, and/or CRO leadership to ensure close site relationships (such as our… more
- Merck & Co. (Rahway, NJ)
- …Estimation and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems, Regulatory ... through cross-functional partnerships with key business units and customers. Your leadership will be instrumental in supporting DS & cell bank commercialization,… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... leadership team, deep modeling expertise and state-of-the-art modeling approaches...of approximately 5-6 pharmacometricians to achieve results on major program drivers by identifying and implementing novel quantitative approaches… more
- Merck & Co. (Rahway, NJ)
- …for R&D projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines approach and ensures ... the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the… more
- Merck & Co. (Montgomery County, PA)
- …budgeting, and launch readiness.Manage day-to-day operations of the patient support program , ensuring timely, high- quality patient interactions and case ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Merck & Co. (North Wales, PA)
- …SAS/GRAPH and systems and database expertise;US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including ... span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.-Design and maintain statistical… more
- BioAgilytix (Durham, NC)
- …Lead will be responsible for building and leading BioAgilytix's global cybersecurity program . This role will set the strategy and oversee execution to strengthen ... ISO 27001).Oversee governance, risk, and compliance activities, including policy development, regulatory alignment (GxP/CLIA, GDPR, Part 11), and global data privacy… more
- NVA (Indianapolis, IN)
- …team at The Paw Patch Place! The Paw Patch Place is an established, busy, high- quality practice that caters to each client and patient on an individual basis. We ... have an amazing clientele and experienced staff that allows us to practice good quality medicine. We strive for quality medicine and surgery in a warm, friendly,… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Commercial Cell Therapy Manufacturing plant. This individual will partner with Plant Leadership and various Technical Operation and Quality functions in support ... will be responsible for management and delivery of the integrated project and program plans in the plant, ensuring alignment in support of the overall objectives… more
- NVA (Sulphur, LA)
- …Director / Managing Veterinarian is primarily responsible for providing medical leadership for the hospital, managing associate veterinarians, and assuring ... regulatory compliance relating to the practice of veterinary medicine....responsible for creating an environment of teamwork in which quality medicine and exceptional client service are consistently delivered… more
- CoxHealth (Branson, MO)
- …of the organization. Addresses facility issues to facilitate the provision of quality efficient care. Provides oversight and management of operational, regulatory ... , and business processes across nursing services. Excellent communication skills, leadership ability, time management, and problem solving skills required. Job… more
