- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic ... deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates ... disorders. Job Summary: Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the ... maintenance of standard hierarchy structures and user access controls for all clinical studies. This position may have direct reports and/or dedicated external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and approval in accordance with ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and forecasting for commercial and IMP relevant activities and QA batch review and release process as necessary.Complaint and Recall Programs Establishment: Manages ... commercial and IMP as a result of distribution practices, manufacturing sites, clinical sites and testing laboratories and assures they are documented and resolved… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... and clinical study report (CSR): Leads statistical activities for complex...for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... the strategic objectives of the organization by bridging the gaps between clinical science and commercialization of our portfolio. The position is dedicated to… 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 ... We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... Identify opportunities for improvement within the customer campaigns and engagement. Review and interpret campaign/tactic data to inform adjustments on customer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scenarios and strategy for all pipeline products starting in Phase II clinical trials. Generates insights to support G3 decision-making Assesses investments in payer ... new and in-line products with resultant break-even elasticity Leads the yearly review of current pricing strategies and owns the process for developing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP CX Manager -CV/Renal will be a critical driver in ensuring the successful execution of brand/therapy ... Identify opportunities for improvement within the customer campaigns and engagement. Review and interpret campaign/tactic data to inform adjustments on customer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight over the site Quality Control laboratories responsible for testing of pre- clinical , clinical , and commercial stage CAR-T cellular therapy products. ... providing quality oversight for site Quality Control laboratories responsible for testing pre- clinical and clinical and commercial stage CAR-T cellular therapy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... and a commitment to excellence in all aspects of clinical practice and scientific exchange. Vision Statement US East...products that reflect prioritized regional and local needs Supports manager in recruiting and onboarding new colleagues May Act… 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 ... or US labels regarding feasibility of promoting potential data/claims with manager oversight Participate/assist in US labeling negotiations as necessary. Ensure that… more
- J&J Family of Companies (Raritan, NJ)
- …follow-up regularly to monitor delivery of all data management milestones. + Review clinical data management documents (including submission package) ensuring ... are searching for the best talent for Analyst II, Clinical Data Manager to be located in...Physician related queries in EDC system. Involvement in other clinical data review activities (eg, Coding, SAE… more
- Mount Sinai Health System (New York, NY)
- …in the NY/NJ region. MSHS, World Trade Center Health Program (WTCHP) seeks a Clinical Pharmacy Manager that reports to Senior Manager , Pharmacy Benefits ... under the direction of the WTCH medical leadership. The Clinical Pharmacy Manager will have direct patient...practitioners as required + Performing prescription audits such as review to improve generic medication use, prescribing patterns and… more
- Molina Healthcare (New York, NY)
- **Job Description** Job Summary Creates and delivers clinical training programs for clinical staff across the enterprise to orient employees to Molina ... clinical methodology, along with policies, processes and systems. Ensures... Social Worker/Counseling (or related field) License Certified Case Manager (CCM), Utilization Management Certification (CPHM), Certified Professional in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... the US and abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is primarily a tactical study delivery… more
