- 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.Provide 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.Represent GRACS within our… more
- Taiho Oncology (New York, NY)
- …collaboration with Medical Affairs personnel supports data generation in Investigator -Initiated Trials (IITs) and SL/HCP initiated projects. Facilitates the review ... and follow-up of submitted IITs in assigned territory with a knowledge of IITs ongoing in other territories. Assists with Taiho sponsored trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and CSR safety narratives- May 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 functions- Accountable for Protocol content/study design development- Contributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol,… more
- Taiho Oncology (TX)
- …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
- BioAgilytix (Boston, MA)
- …by the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator )independently creating reports, plans, and submission documents in support of ... internal BioAgilytix projects Extracts and formats data from multiple lab systems (eg, LIMs, SoftMax, FACs) to generate reportsEssential Responsibilities: System FacilitatorSupport system implementation and updates, such as Watson LIMS or automation; liaise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and other cross-functional and regional stakeholders. Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in ... Global IIS Review Committee meetings.- Collaborates across functions to support GMA Medical Information Education activities to achieve approval of key scientific communication resources such as medical information response documents, (non-) promotional… more
- Lundbeck (Miami, FL)
- …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
- Tris Pharma (Monmouth Junction, NJ)
- …to safety sections of key study documents such as (ie, Investigator Brochures, protocols, statistical analysis plans, informed consent forms, Clinical Study ... Reports (CSRs), etc.); Provides expert safety guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials Assists in preparation of response to regulatory inquiries related to safety; Prepares… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application summary documents, etc. Research and analyze the ... evolving competitive and regulatory landscapes to maintain current knowledge Effectively manage timelines while working in a fast-paced and dynamic environment across both time zones and cultures Physical Requirements 10-20% overnight travel required. Ability… more
- Spectraforce Technologies Inc (North Chicago, IL)
- …Clinical Study Agreements, Confidential Disclosure Agreements, Master Agreements, Investigator Initiated Agreements, Service Agreements ect In partnership with ... for Clinical Study Agreements, Confidential Disclosure Agreements, Master Agreements, Investigator Initiated Agreements, Service Agreements, and any other procurement… more
