- Merck & Co. (Rahway, NJ)
- …teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization. -Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates ... Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic ... . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Merck & Co. (North Wales, PA)
- …protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and ... (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection... Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …protocol in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and ... . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data... Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance ,… more
- Merck & Co. (San Francisco, CA)
- …Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will ... Skills:Budget Development, Business, Clinical Supply Chain Management, Clinical Trial Management, Compliance Frameworks, Cross-Cultural Awareness, Decision… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit ... QualificationsMust have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to ... areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA)… more
- Merck & Co. (Rahway, NJ)
- …Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation and filling ... of clinical and developmental supplies for sterile products, including critical...and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Merck & Co. (North Wales, PA)
- …President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction ... and study design, analysis strategy, and analysis results with highest quality . This individual is responsible for hiring appropriate, qualified staff, coaching… more
- Merck & Co. (Durham, NC)
- …to manufacturing areas and operating under the direction of the Logistics Manager . Must adhere to current Good Manufacturing Practices, Standard Operating Procedures ... nonconforming material from stock, place in quarantine and notify Quality Inspector of non-conformance.Pick material based on transfer request requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. ... Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable for… more
- Merck & Co. (Rahway, NJ)
- …allocating resources for cross-product delivery and coordinating with investment Manager to ensure appropriate coordination and forecasting.Communicate IT strategy ... (Analytical R&D) , PR&D (Process R&D) and PSCS (Pharmaceutical Sciences and Clinical Supply) functions.Understanding of the business workflows across the Discovery /… more
- BioSpace (New York, NY)
- …(CRO) clinical trial services, with a primary focus on ensuring quality Clinical Research Associate (CRA) monitoring and data integrity across all ... needs via oral or enteral routes. Job Overview: The Clinical Trial Manager (CTM)/ Clinical Research...performance aligns with sponsor expectations, with a focus on quality monitoring, site issue resolution, and protocol compliance… more
- Guidehealth (Dallas, TX)
- …value inside and outside the exam room for all patients. Job Description The Manager , Clinical Care is primarily responsible for the day-to-day operations of an ... integrated multi-disciplinary clinical and clinical support structure that will...and community resources/social services are provided as indicated. Ensuring Quality Measures are reviewed and addressed when applicable/appropriate Implementing… more
