- Merck & Co. (North Wales, PA)
- …and goals for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The RMSD serves as a role model for ... the comprehension of the scientific foundations and goals of investigator -sponsored researchIdentifies barriers to patient enrollment and retention efforts to… more
- Merck & Co. (Rahway, NJ)
- …of data management tools.Provide inputs in to the preparation of the investigator meetings materials and makes him/her available for questions. May present data ... management instruction at investigator meetings based on business need and management decision.Participate in relevant operational meetings to identify and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a Global IIS Review Committee, for ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… 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
- Tris Pharma (Monmouth Junction, NJ)
- …briefing documents, Investigational New Drug (IND) annual reports, Investigator 's Brochures, clinical study reports and scientific presentations including ... consent forms, regulatory forms (IND sections, clinical study reports, Investigator ’s Brochures), scientific publications/presentations, etc.) Working knowledge of medical… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …and supervise the deviation investigation team, assign deviations based on investigator skill/experience and deviation type, ensure level-loading of investigator ... workload, and identify and support training and development opportunities to advance investigators' skillsets. Mentor and coach investigators Identify and deploy advanced investigational techniques to support more effective investigations and identification of… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …a variety of animal models of disease; and may serve as the principal investigator or study director on a variety of sponsored programs; supervise and oversee the ... of disease models and safety/efficacy studies; support and develop investigator -initiated sponsored research programs; and perform all other related duties… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to team members and track them to completion. Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks. Perform ... investigations and train new investigators. Collaborate with team to determine if corrective actions adequately addressed root cause of NC event. Support tracking of deviations, events and key process parameters and provides reports to management on trending,… 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
- 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 (NJ)
- …clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and review marketing ... application submission documentsAt the Director's discretion, may provide work direction to vendors/ contractors/consultants Contributing to process improvement within and across functional areas by obtaining feedback for improvements for document processes,… 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
- BioAgilytix (Durham, NC)
- …needs based on projected project needsMay serve as principal investigator on a projectMay prepare and submit deviationsManage project timelines/schedulingManage ... budget and revenue for projectsCommunicate with clientTrain analysts/junior scientistsDevelop assay independentlyAbility to assist with definition of project scope and proposal preparation (SME)Prepare and review scientific training materialsSet up studies in… 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
- 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)
- …the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a Global IIS Review Committee, for ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… 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 external 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
