- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The GCO Senior Director of Study Optimization has accountability for the oversight, management, and ... modeling to analyze historical performance metrics, epidemiology data, and investigator /site capabilities to support selection decisions. Ensure internal/external databases… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a US IIS Review Committee, for ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a Global IIS Review Committee, for the ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… more
- Eisai, Inc (Nutley, NJ)
- …planning. Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials.Serve as primary ... Transparency Language:The base salary range for the Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Oncology - New Jersey and Long Island… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is ... and other cross-functional and regional stakeholders.- Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, ... and execution of Interventional, Non-Interventional, Managed Access Programs, and Investigator -Initiated Studies.Provide comprehensive quality oversight for Medical Affairs activities,… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …sections of regulatory documents including, IND submissions, annual updates, DSUR, investigator brochures, and briefing documents. 2. Study specific documents such ... and clinical trial results at internal or external meetings. 6. Communicate to Senior Management and relevant functions any potential issues, risks or changes to the… more
- Elevance Health (Morristown, NJ)
- ** Investigator Senior ** **Supports the Payment Integrity line of business** **Hybrid 1:** This role requires associates to be in-office **1-2** days per week, ... determined to recover, eliminate and prevent unnecessary medical-expense spending. The ** Investigator Senior ** is responsible for the independent identification,… more
- Bristol Myers Squibb (Summit, NJ)
- …Read more: careers.bms.com/working-with-us . **Position Summary** Cell Therapy Network Lead investigator will support the commercial and late stage clinical cell ... for complex trend investigations stemming from deviations and SAEs. The lead investigator will assemble and lead cross functional matrix teams necessary to close… more
- Deloitte (Morristown, NJ)
- AML Consultant-Project Delivery Senior Analyst- Regulatory, Risk & Forensic Operate Are you an experienced, passionate pioneer in technology who wants to work in a ... collaborative environment? As an experienced AML Project Delivery Senior Analyst you will have the ability to share new ideas and collaborate on projects as a… more
- Bayer (Newark, NJ)
- …and diverse minds to make a real difference, there's only one choice.** ** Senior Medical Science Liaison Stroke/Thrombosis New York New Jersey** Senior Medical ... **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Senior Medical Science Liaison, Stroke/Thrombosis are to: **Scientific Expertise** +… more
- Bristol Myers Squibb (Madison, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary** This ** Senior Director,** **Immunology & Neuroscience (I&N), Medical Evidence Generation ... Affairs Sponsored studies [MAST], Clinical Research Collaborations [CRC], and investigator -sponsored studies [ISR]) and provides leadership for the cross-functional… more
- Bristol Myers Squibb (Madison, NJ)
- …BMS clinical trials from study start to database lock. **Position Summary** The Senior Manager, Clinical Data Management is a leadership role considered essential to ... + Excellent oral and written communication skills. Communicate effectively with senior management and cross-functional teams + Knowledge of submission requirements,… more
- Regeneron Pharmaceuticals (Warren, NJ)
- The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or ... clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study… more
- Sanofi Group (Bridgewater, NJ)
- …stretch the limits of what you thought was possible. Ready to get started? The Senior Clinical Research Director (Sr CRD) is noted as the **primary clinical lead for ... deliver to multiple operational tasks. The role of the Senior CRD is to: + Act as a mentor...and/or contribute in the the clinical section of the Investigator 's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP +… more
- Deloitte (Morristown, NJ)
- …case dispositions + Holding meetings with Project Leadership to discuss investigator performance, issue management, and case escalation decisions + Providing ... related software + 4+ Years Experience submitting written and oral reports to senior management and clients + Bachelor's degree preferably in Finance, Business, Law,… more
- IQVIA (Parsippany, NJ)
- …are available for filing in the Trial Master File (TMF) and verify that the Investigator 's Site File (ISF) is maintained in accordance with GCP / ICH and local ... regulatory requirements. * Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. * Act as a… more
- Sanofi Group (Morristown, NJ)
- …external sponsor) for Externally Sponsored Research (ESR) support, including Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC). The ... Committee (SRC). The role reports directly to the Sanofi Senior Manager, ESR Operations. We are an innovative global...ESR. + Supports dissemination of safety updates and Dear Investigator Letters (DILs). + Ensures stakeholders are trained and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and CRA training materials and presentation at site initiation visit and Investigator meetings and support on Study committee (eg, DMC, protocol review committee). ... verbal and in writing (English). + Ability to communicate effectively with senior management and colleagues. + Strong negotiation and conflict resolution skills. +… more
- Deloitte (Morristown, NJ)
- …case dispositions + Holding meetings with Project Leadership to discuss investigator performance, issue management, and case escalation decisions + Providing ... related software + 4+ Years Experience submitting written and oral reports to senior management and clients + Bachelor's degree preferably in Finance, Business, Law,… more
