- Merck & Co. (North Wales, PA)
- … data/medical protocol deviations in collaborations with the Clinical Director.Other responsibilities include:Collaborating cross-functionally in the development ... writing, and presentation skillsEducation/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development , project management, and/or medical… more
- Merck & Co. (Rahway, NJ)
- …globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM)...GCS and serve s as the GCS spokesperson at clinical development related meetings (i .e., … more
- Merck & Co. (Rahway, NJ)
- …globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... of the GCS Planning organization. -Working independently, the Inventory Manager Clinical Supplies Project Manager ... process & connectivity between functions supporting pipeline (ie clinical development , CMC, supply chain, & human… 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 ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...utilizing Standard Problem Solving (SPS) methods and strong CAPA development within the NN deviation IT platform Serve as… 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 ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...management, and system management to influence process and system development in a manner consistent with global affiliate health… more
- Merck & Co. (Rahway, NJ)
- …globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves... process & connectivity between functions supporting pipeline (ie clinical development , CMC, supply chain, & human… more
- Genmab (NJ)
- … Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve… more
- Genmab (NJ)
- …components of regulatory submission (NDA, BLA, MAA) highly preferred.Solid understanding of clinical development and regulatory frameworks, including GCP and ICH ... At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us...our Global Medical Writing team, you will drive the development of high-quality clinical documents to support… more
- Merck & Co. (Rahway, NJ)
- …best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This ... ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):N/ARequired Skills:Adaptability, Capital Projects, Clinical Development , Detail-Oriented, Deviation Management, Equipment Qualification,… more
- Eisai, Inc (Nutley, NJ)
- …Director, Clinical Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This ... JReview within IODS. Reporting to the Assoc. Director of Clinical Programming is the senior level highly...Reports for data review & cleaning Manage standard tools development & enhancement related to clinical data… more
- ACROBiosystems Inc. (New York, NY)
- …and manufacturing recombinant proteins and critical reagents/assays to support drug development and clinical applications from target discovery and validation, ... candidate drug screening and optimization, CMC development , preclinical and clinical studies, commercial production, and companion diagnostics. We are committed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and ... will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above by...developing and writing corresponding SAS or other programs. The Senior Programming Manager may also serve as… more
- Novo Nordisk Inc. (Hackensack, NJ)
- …passion and engagement are met with opportunities for professional and personal development . Are you ready to realize your potential? The Position This position ... The EDCS must achieve sales goals by utilizing a patient-centric and clinical approach to engaging their customers and promoting Novo Nordisks portfolio of… more
- Merck & Co. (North Wales, PA)
- …with senior cross-functional leadership to optimize efficiencies in the clinical development space. Preferred skills include experience in the application ... BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP...a direct manager and a second line manager (ie, managers of managers)Demonstrated collaboration with senior… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development , and performance ... 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… more
- Novo Nordisk Inc. (San Mateo, CA)
- …passion and engagement are met with opportunities for professional and personal development . Are you ready to realize your potential? The Position Assumes ... current co-promotion partners. Internally, the DCS reports to the District Business Manager of the specific sales territory. The DCS also interacts and collaborates… more
- Bristol Myers Squibb (Princeton, NJ)
- …Squibb's mission to advance clinical development through data-driven innovation, the Senior Manager - Analytical AI in Clinical Development will ... + Develop and execute detailed project plans that align with clinical development timelines, ensuring timely delivery of AI solutions. + Conduct post-deployment… more
- CVS Health (Austin, TX)
- …and every day. **Position Summary** We are seeking a highly skilled and experienced ** Senior Manager , Software Development Engineering - ML/AI Products** to ... lead our software development team in delivering innovative clinical products that enhance patient care and streamline operations within the healthcare domain.… more