- Daiichi Sankyo, Inc. (Munich, ND)
- …global regulatory operations , biostatics, data management, clinical science and clinical operations . The Network Lead will have direct accountability ... disorders. Summary The Oncology Early Development Center (OEDC) Network Lead is 100% dedicated to OEDC and will provide...assessing potential new FIH sites and in FIH site clinical operations methods required.Experience in site selection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans ... compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Merck & Co. (Rahway, NJ)
- …Point of Contact (POC) for assigned protocols and link between Country Operations -and clinical trial team (CTT).Responsible for project management of the ... Operations .Collaborates internally with HQ functions, regional and local operations , EU Clinical -Development, Pharmacovigilence, Global Medical Affairs to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …setting, to drive the development of potential products and drug candidates. The Manager, Clinical Pharmacology will support or take the lead on generation of ... with external CROs, collaborate and represent QCP on internal teams including Clinical Development Operations , Global Project Management, Bioanalysis, and Drug… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... outsourcing of clinical services to Clinical Research Organizations (CROs)...vendor selection and management options in alignment with global strategies. Lead the process of Request for Proposal (RFP) development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... and adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and Delivery ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Medical & Regulatory (CMR), Future Business Strategy (FBS), Strategic Operations (SO, Human Resources. Key global stakeholders include: various… more
- Merck & Co. (Rahway, NJ)
- …standards and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards ... Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to ... checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates… more
- Merck & Co. (Rahway, NJ)
- …of the FLEx complex is shared across two co-leader roles, and includes operations that support end-to-end GMP clinical supply manufacture and product/process ... based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research and Development Division (R&D).-… more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related drug/vaccine projects in … more
- Merck & Co. (North Wales, PA)
- …process owners in GCD and GCTO like our company's IT, Medical Monitors, Clinical Scientists, Clinical Quality Operations Managers (CQOMs), GDMS, BARDS ... that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation &...Under the oversight of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Process Trainer will be responsible for performing process training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy ... Leads, coaches and delivers a holistic, effective process qualification program for Operations trainees who support daily clinical production and strategically… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical ... Program Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites...our CMO's and internal packaging sites for GMP processing operations . This position will work with a label translation… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Business Platform lead in the Platform Team plays a crucial role in analyzing business requirements, facilitating communication between ... in pharmaceutical industry or any regulated industry will be desirable. Clinical systems knowledge highly preferred.#EligibleforERP MRLGCTO#ONEGDMSNOTICE FOR INTERNAL APPLICANTSIn… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …up, model the way and enable the team to act.Provides medical leadership toGMA clinical operations teams as part of evidence generation forums and study teams ... management from a medical perspective -Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and planning alignment across the matrix team consisting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of ... treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor (2nd shift) as part of the Technical...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead QC Microbiology Data ... treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the...surface sampling, related to Raritan manufacturing processes, either for clinical trials and commercial operations in a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and ... Operations team works closely with the business across the...focus on operational excellence in support of patient needs Lead design, implementation and ongoing management of all Rare… more
