- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical Safety Scientist Product Lead and PSL - May serve as a project manager for other activities involving assigned product(s) or clinical studies, ... assigned clinical studies - CTD submissions/Others - May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... and dashboards of key regulatory data/metrics from across systems, leveraging technical integrations and automation where possible, and using analytics tools to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, ... etc., under the direction of Director, Compliance Policy, Training and Communications. Project manage various teams to build creative training programs from… 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 support continued development of Patient Safety staff through training. Leads project activities and needs related to Patient Safety. Ensures compliance with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… 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 ... Exercises considerable latitude and applies extensive pharmacovigilance knowledge and technical expertise in determining and implementing strategies consistent with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …during preparation and review of regulatory documents As assigned, participate in project teams Assist with technical preparation for FDA meetings, including ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...make a difference? The Position Provide proactive support and technical assistance to more experienced regulatory personnel. Identify issues… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oncology Value Pricing & Access, and will be responsible for providing strategic and technical expertise to drive the success of the asset. As per life cycle ... and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role Overview This position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in ... of multiple myeloma. Legend Biotech is seeking a Senior Manager /Associate Director, External Manufacture as part of the Global...organization. He/she will be the business owner of the project : overseeing the project , driving the deliverables,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the ... Technical Operations team based in Raritan, NJ. Role Overview...responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual… more
- Catalent (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with...and Catalent employee. The Role Support activities of the Manager , Training Program and the Training Lead.Cross train with… more
- Merck (West Point, PA)
- …**Position Description:** ** Manager , Operations and Reference Data Management, Global Clinical Data Standards** Working closely with the Global Clinical Data ... in quality, efficiency, and productivity across the organization. Keeps abreast of project management, clinical data standards, and regulatory requirements for … more
- Philips (Mercerville, NJ)
- … and Technical resources in coordination with the hospital provided project manager or point(s) of contact. + Responsible for effectively communicating ... Your role as Customer Project Manager is to manage multiple...be responsible for leading a clinical and technical team for each project , to ensure… more
- J&J Family of Companies (Raritan, NJ)
- Lead Clinical Data Manager - Ethicon, Inc. - 2406171910W **Description** Ethicon, Inc, part of the Johnson & Johnson family of Medical Device companies, is ... current recruiting for a **Lead Clinical Data Manager ** . _This role will...data management related contributions remain on target per the project timelines. * Ensure data quality through proactive independent… more
- Cardinal Health (Trenton, NJ)
- …Surveillance Plans and Clinical Evaluation Reports for the medical devices. The Project Manager has medical writing experience, strong project management ... Medical Writing contributes to Cardinal Health_** The Medical Writing Project Manager is a member of the...of research methodology and the ability to develop high-quality clinical documents. Extensive knowledge of the European medical device… more
- Fresenius Medical Center (Somerville, NJ)
- **About this role:** As a Clinical Manager with Fresenius Medical Care, you will ensure that quality patient care is delivered while maintaining clinical ... functions, leading your business, and advanced leadership. As a Clinical Manager , you may advance your career...reports. + Partners with internal Human Resources, Quality, and Technical Services departments. + Collaborates with or functions as… more
- Bausch Health (Bridgewater, NJ)
- …systems and procedures are efficiently and correctly completed + Collaborates on project teams, primarily with Clinical Operations, Research and Development, ... + Leads or collaborates on required tasks prior to commencement of senior clinical trials that include, but are not limited to: clinical planning,… more
- Kelly Services (Horsham, PA)
- …better positioned to treat the individuals in their care. The CAR-T Cell Therapy Experience project manager is a member of this account management team. The role ... are completing the site certification process for new sites. The Cell Therapy Project Manager will manage activities associated with the site certification… more
- Philips (Mercerville, NJ)
- … Clinical and Technical resources in coordination with the hospital provided project manager or point(s) of contact. + Ensure site readiness and adherence ... business **Your role:** + Your role as a Solution Project Manager will be to manage multiple...or an equivalent combined experience/education in the areas of: Clinical or Computer Science, Information Technology, Project … more
