- Merck & Co. (North Wales, PA)
- …interest to the company. The RMSD provides research support to our Investigator -Sponsored and Company-Sponsored Trials to enhance the understanding of the scientific ... patient enrollment and retention efforts for a given study or address Investigator questions. RMSDs also respond to scientific questions from SLs, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provides market-oriented medical input to trial design, protocol development, and investigator selection in NN clinical trials For Phase IIIb and IV, drives ... design protocol development according to market oriented medical input and investigator selection in NN clinical trials Drive additional clinical activities beyond… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provides market-oriented medical input to trial design, protocol development, and investigator selection in NN clinical trials For Phase IIIb and IV, drives ... design protocol development according to market oriented medical input and investigator selection in NN clinical trials Drive additional clinical activities beyond… more
- Merck & Co. (North Wales, PA)
- …increase participation in studies of Our Company compounds by increasing investigator awareness of research opportunities supported by Our CompanySupport Our ... Company's Investigator -Initiated Study Program (IIS) through field-based support of Areas...FMPIncorporates Scientific Platform, including insights and voice of the investigator , into the execution of Field Medical strategies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of investigators for clinical studies and provide medical support to investigator meetings Provide protocol training, disease specific training and titration ... and/or review clinical sections of clinical trial reports, statistical reports, investigator 's brochures, INDs, NDA and responses to Regulatory questions Provide… more
- Merck & Co. (Rahway, NJ)
- …approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external ... agencies and investigators.Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.Represents GRACS within our… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Data Transfer documents.Review of clinical protocols, laboratory instructions, investigator training, clinical sample analysis, archiving of biomarker test ... results, and regulatory submission activities for Daiichi Sankyo clinical development.Contributes on biomarker related sections of clinical study protocols and ensure instructions on sample collection, processing and shipping requirements are translated into… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Scientist Lead and PSL to author safety sections of the Investigator 's Brochure, aggregate reports (DSUR/PLL), prescribing information, Company Core Data Sheet ... (CCDS), Risk Management Plans (RMPs).Contributes to regulatory authority requests or communication for assigned clinical studies.CTD Submissions / OtherMay support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Scientist Lead and PSL to author safety sections of Investigator 's Brochure, aggregate reports (DSUR/PLL), Prescribing Information, Company Core Data Sheet ... (CCDS), Risk Management Plan(s) (RMPs).Contributes to regulatory authority requests or communication for assigned clinical studies.CTD Submissions / Others:May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist… more
- Merck & Co. (Rahway, NJ)
- …well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols. - Support the collection of clinical suppl ... y chain metrics and/or participate in critical non-pipeline activities. - Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies . - Mentors new team members and supports staff development, as… more
- Merck & Co. (Rahway, NJ)
- …support for US regional symposia and educational meetings.Reviews investigator -initiated study proposals prior to headquarters submission.Manages regional programs ... (patient support, educational or risk management) to support appropriate and safe utilization of our Company medicines.Required Education Minimum:MD, PhD or PharmD (MD preferred) and recognized medical expertise in the therapy areaRequired Experience and… more
- Insmed Incorporated (San Diego, CA)
- …Develops/provides input to product Benefit-Risk Assessments, Company Core Data Sheet, Investigator Brochure and Risk Management Plans (RMPs), and Risk-Evaluation and ... Mitigation Strategies (REMS). Ensures, in collaboration with Regulatory Affairs labeling team, an accurate representation and communication of the safety profile of assigned products and development compounds. Responsible for preparing responses to inquiries… more
- Taiho Oncology (FL)
- …In collaboration with Medical Affairs personnel support data generation Investigator -Initiated Trials (IITs) and HCP initiated projects. Facilitate the review ... and follow-up of submitted IITs. Assist with Taiho sponsored trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site initiation or training meetings, and communication of scientific insights for… more
- Genmab (Plainsboro, NJ)
- …strategies and to support product launches and lifecycle management.Monitor ongoing investigator sponsored trials (IST) and health economics and outcomes research ... (HEOR) data generation that support the indication strategies; and ensure the effective dissemination of the data generated.Participate in the review of congress abstracts, posters, presentation slides, manuscripts, educational materials, advisory board… more
- Lundbeck (Dallas, TX)
- …gaps Identifies and facilitates the submission of grant requests and investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request, ... assists in clinical trial and research efforts by recommending qualified investigators and research sites and conducting site outreach and support Fulfills unsolicited requests for medical information from health care professionals Actively participates in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experts in Oncology including advisory boards, Congress activities, and investigator initiated studies, advocacy and sponsorships. Interact with investigators and ... members of the medical community to assist in understanding current academic, clinical trial and practice issues related to DS Oncology development and therapeutic strategies.- Partner with the commercial teams to oversee and assume responsibility for brand… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(TLF) and CSR safety narrativesMay lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the ... other sections in collaboration with the other authoring functionsAccountable for Protocol content/study design developmentContributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol,… more
- Southern New Hampshire Health (Groton, MA)
- …we have developed. About the Job: Oversees the overall operation of each investigator site within Foundation Medical Partners. The Clinical Trials Manager acts as a ... liaison between the investigator site and the Administrative Research Committee for Foundation Medical Partners. What You'll Do: Understands each of the operational… more
- Iowa Department of Administrative Services (Des Moines, IA)
- Investigator 2 - Wage and Child Labor Print (https://www.governmentjobs.com/careers/iowa/jobs/newprint/4864117) Apply Investigator 2 - Wage and Child Labor ... of Inspections, Appeals, and Licensing (DIAL) is seeking an Investigator to join our Wage and Child Labor Unit....equal to one year of full-time work as an investigator requiring knowledge in law enforcement, corrections, or criminal… more
