- 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
- Piper Companies (Salt Lake City, UT)
- Piper Companies is searching for a Clinical Trial Physician / Principal Investigator in Salt Lake City, Utah. The Principal Investigator will lead clinical ... included (Health, Dental, Vision, 201k, PTO, etc.) Keywords:Clinical research, investigator , clinical trial physician, family medicine, family practice, internal… 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)
- …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)
- …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 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)
- …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
- Merck & Co. (North Wales, PA)
- …development of local data generation study concepts and protocols.Reviews 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 vaccines.Required Qualifications, Skills & Experience: Minimum education required: MD, DO (or equivalent medical… 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
- 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
- Catalent (Philadelphia, PA)
- …and SOPs related to batch record documentation and release.Act as lead investigator for all Problem Reports regarding batch record documentation and support Problem ... Reports led by Operations.Interact with customers regarding questions, issues, metrics, batch records, etc; Respond to and investigate customer complaints.Audit for compliance as pertains to Catalent SOPs, regulatory, & customer requirements.Perform all… more
- Catalent (Philadelphia, PA)
- …"Good Manufacturing Practices" and "Good Distribution Practices"Act as lead investigator for all compliance issues regarding incoming, distribution, returns, ... destruction, or packaging/productionDevelop process excellence and efficiencies prior to the beginning of a project; Track and report metrics and identify trends and predictive modelsReview and revise SOPs/Forms, Distribution Summaries/Checklists, and Returns… 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
