- 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
- 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
- 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 ... 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. (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 ... 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. (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.Leads selecting medical education and other scientific exchange activities in alignment with the Senior Director, such as scientific symposium and medical congresses, within legal and compliance regulations.Collaborates… more
- Eisai, Inc (Nutley, NJ)
- …vendors, develops and maintains client relationships.As project lead/principal investigator has project budget, deliverable and timeline responsibility; identifies ... scope expansion and need for project amendments.Mapping of payer/HTA engagement timelines for key global markets and coordinate stakeholders' engagement and responses to HTA and reimbursement challenges in close collaboration with Global, Regional, and local… more
- Eisai, Inc (Nutley, NJ)
- …advisory boards, health outcomes plans, MSL activities, speaker programs, investigator -initiated research and CME grant reviews or other internal key ... business processes. Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. 20%External leadership: Provides leadership and strategic direction… more
- Eisai, Inc (Nutley, NJ)
- …coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information collection, processing, ... tracking and distribution; Interact with health professionals and consumers regarding post-market adverse experiences, and clinical investigators and their staff regarding AE's from clinical trials. 30%Assist in projects requiring review and assessment of… more
- Eisai, Inc (Nutley, NJ)
- …advisory boards, health outcomes plans, MSL activities, speaker programs, investigator -initiated research and CME grant reviews or other internal key ... business processes. Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas.External leadership: Provides leadership and strategic direction to… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgets.Collect ... to supervisor's attention.Track study metrics such as site start-up, Investigator /site performance, recruitment, regulatory documents, TMF filing and QC activities… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships, developing and maintaining strong communication channels. Leads successful investigator and strategic partnership negotiations in accordance with all ... materials and ancillary supplies to North America distribution depots, and/or investigator sites across North America. This includes collaborating with customers and… more
- Insmed Incorporated (Bridgewater, NJ)
- …including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD ... submissions, and responses to questions from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.Production of tables, listings and narratives of safety areas of… 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
- MTA (New York, NY)
- Senior Equal Opportunity Investigator Job ID: 4633 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: Date ... and the Director of Investigations, the Senior Equal Opportunity (EO) Investigator partners with Agency management to develop, coordinate, implement, enforce and… more
- MTA (New York, NY)
- Equal Opportunity Investigator Job ID: 6840 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: Date Posted: ... Apr 24, 2024 Description JOB TITLE : Equal Opportunity Investigator SALARY RANGE : $90,000 - $95,000 HAY POINTS : 451 DEPT/DIV : Department of Diversity & Civil… more
- City of New York (New York, NY)
- …Employment Opportunity & Diversity Office seeks to hire an experienced EEO Investigator who will be responsible for conducting complex complaint investigations, as ... supervising more junior investigators in the execution of their assignments. The EEO Investigator will report directly to the Assistant Commissioner of EEO&D or the… more
