- TechWerks (Silver Spring, MD)
- TechWerks, LLC seeks a Principal Investigator to support the prestigious Center for Military Psychiatry and Neuroscience (CMPN) award in collaboration with the ... Walter Reed Army Institute of Research (WRAIR). The Principal Investigator (PI) will play a pivotal role in the Medical Readiness Systems Biology (MRSB) program,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position The Deviation Investigator -Writer is responsible for investigating and writing of deviations to the ... merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations and writing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Support Fair Market Value process in evaluating study ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on investigator skill/experience and deviation type, ensure level-loading of investigator workload, and identify and support training and development ... Deviation Investigation organization and working with site leadership to strengthen and support a learning culture across the site. This role involves leadership and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …the development and evaluation of disease models and safety/efficacy studies; support and develop investigator -initiated sponsored research programs; and perform ... of advancing and bettering human health.At Lovelace Biomedical, we support a bevy of exciting advanced research and development...models of disease; and may serve as the principal investigator or study director on a variety of sponsored… more
- Taiho Oncology (TX)
- …personnel. Medical Affairs personnel. In collaboration with Medical Affairs personnel support data generation Investigator -Initiated Trials (IITs) and HCP ... is non-promotional in nature. Responsibilities and Duties: Product/Therapeutic Area Support to External Stakeholders: Act as the primary clinical/scientific resource… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in review of investigator -initiated studies (IIS) and may ... select medical affairs projects within a specific compound or indication. Responsibilities Support GMA the development of the Global Medical Affairs strategy and… more
- WSFS Bank (Wilmington, DE)
- …their careers, guide our customers to secure their financial futures, and actively support our Communities so they can fully thriveCareers with WSFS Bank offer an ... our name, it's our mission and our purposeThe Fraud Investigator I is primarily responsible for the investigation and...Customers to secure their financial futures, and we actively support our Communities so they can fully thriveWe know… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with GMA Clinical Operations and other cross-functional and regional stakeholders. Provides support in review of investigator -initiated studies (IIS) and may ... lead in Global IIS Review Committee meetings.- Collaborates across functions to support GMA Medical Information Education activities to achieve approval of key… more
- Merck & Co. (North Wales, PA)
- …Medical Writer is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior ... preparing clinical regulatory documents (eg, protocols, clinical study reports, investigator 's brochures, clinical sections of submissions) per company and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.Ensure study budget is reconciled with Finance ... on an ongoing basis. Support all inspection readiness and quality initiatives pertaining to...Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.Ensure study budget is reconciled with Finance ... on an ongoing basis. Support all inspection readiness and quality initiatives pertaining to...Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... relationships, developing and maintaining strong communication channels. Leads successful investigator and strategic partnership negotiations in accordance with all… more
- Taiho Oncology (New York, NY)
- …MSL is non-promotional in nature. Performance Objectives: Product/Therapeutic Area Support to External Stakeholders: Acts as the primary clinical/scientific resource ... tactical plan for MSL geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned territory, eg, medical territory,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and controls a library of educational slides to be used for Investigator Meetings, Site Initiation Visits (SIVs) and other educational needs across assetsPartners ... and in alignment with stakeholdersSpecific project assignments may include support in creating and deploying training materialsThe Associate Director, GOCD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle Independently leads ... Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle - Collaborates with… more
- Merck & Co. (North Wales, PA)
- …development of local data generation study concepts and protocols.Reviews Investigator -Initiated Study proposals from key countries prior to headquarters submission ... (ex-USA)Manages programs (patient support , educational or risk management) to support appropriate and safe utilization of Our Company medicines or… more
- Merck & Co. (Rahway, NJ)
- …by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.Review and provide final ... Affairs International (RAI), and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions… more
- Daiichi Sankyo, Inc. (Nashville, TN)
- …leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. ... and study committee members for DSI clinical research programs, 2) investigator -initiated research study proposals, 3) speakers for DSI Brand Speaker programs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides oversight to the CRO MM for clinical data review activities- May support addressing eligibility and medical questions from sites/ IRBs- May provide medical ... narratives- May lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead...as pre-submissions, end of phase 1/2, and inspections- May support the GCL, if applicable, in planning and executing… more
