- 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)
- …and to improve outcomes for patients.The EDSA leads a large investigator -initiated studies program in partnership with late-stage development teams in Medical ... comprehensive Congress summary reports. Primary Responsibilities: Leads our Company's Investigator Initiated Studies program for our cardiovascular portfolio (Atherosclerosis,… more
- Merck & Co. (Rahway, NJ)
- …in a timely manner in coordination with the study CRM.Attend local Investigator Meetings if requested to.Interface with GCTO partners on clinical trial ... execution.Escalates site performance issues to CRM and Clinical Research Director CRD.People and Resource Management:Manage CRA - career development, performance reviews, etc., including addressing low performance situations, and taking appropriate… more
- Merck & Co. (Rahway, NJ)
- …trials run in-house, 400+ outsourced or run by partners, and 300+ company Investigator Initiated Studies (IIS) clinical trials. GCS is accountable for the planning, ... sourcing, labeling, packaging, and delivery of clinical supplies to clinical sites across more than 60+ countries, in accordance with US and Global regulations, company policies, and Standard Operating Procedures. --Your Fellowship Project--Ensuring treatment… 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)
- …with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect ... to supervisor's attention.Track study metrics such as site start-up, Investigator /site performance, recruitment, regulatory documents, TMF filing and QC activities… 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.Continuously ensures compliance with Eisai policies and procedures for all activities undertaken and monitors various government and industry guidelines to best practices. Requirements This position requires a dynamic individual with a PhD… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- 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)
- …Operations Leads in the 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. 4. Contribute to propose, establish, and optimize more productive standardized working processes for clinical biomarker assay development and support. Qualifications: (What are the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management preferably with a sponsor company at a global level. Prior investigator site and/or monitoring experience is advantageousProven track record of providing ... feasibility related services and value to organization(s)Demonstrated success in working cross-functionallyTravel: Ability to travel up to 10% Remote by Design. May require some travel (domestic or global)Daiichi Sankyo, Inc. is an equal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documentsAuthors or oversees the development of safety sections of Investigator 's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data ... Sheet (CCDS), Risk Management Plan(s) (RMPs)Collaborates with PSL(s) and cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communicationEnsures consistent and unified safety message throughout multiple… 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 assets. ... Partners with IT to ensure information is available both internally and externally via intranet / internet.- External collaboration: Interacts with external development partners to ensure consistency in materials development. Maintains a shared, collaborative… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator -sponsored studies (ISS) and provide comments to RGC Chair Attend ... in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator 's Brochure (IB), integrated safety summaries, abstracts and planned publications ... by participation in project/trial groups/teams established, as appropriate and conducts Investigator training as required Provide answers to enquiries from HAs and… 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
