- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position The Deviation Investigator -Writer is responsible for investigating and writing of deviations to the ... merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations and writing… more
- Merck & Co. (North Wales, PA)
- …preparing clinical regulatory documents (eg, protocols, clinical study reports, investigator 's brochures, clinical sections of submissions) per company and ... a subset of clinical regulatory documents (eg, clinical study reports, investigator 's brochures, clinical sections of submissions) per regulatory requirements and… 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
- 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
- Merck & Co. (Rahway, NJ)
- …development of local data generation study concepts and protocolsReviews Investigator -Initiated Study proposals from key countries prior to headquarters submission ... (ex-USA)Manages programs (patient support, educational or risk management) to support appropriate and safe utilization of Our Company medicines or vaccinesPosition Qualifications: Education Minimum Requirement: MD, Ph.D. or Pharm.D. (MD preferred) and… more
- Lundbeck (Boston, MA)
- …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
- 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
- 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
- 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)
- …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.External leadership: Provides leadership and strategic direction to… 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. 20%External leadership: Provides leadership and strategic direction… 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 assetsPartners ... 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 developmentMaintains a shared, collaborative e-workspace… 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
- 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. (Nashville, TN)
- …and study committee members for DSI clinical research programs, 2) investigator -initiated research study proposals, 3) speakers for DSI Brand Speaker programs, ... 4) advisors for DSI scientific, clinical and marketing advisory boardsGathering customer insights regarding DSI and competitor products to help inform medical and commercial decision makingEnhanced professional expertise through attendance of select scientific… 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
