- 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …direct/indirect referral: Incumbent will have mix of direct and indirect-matrixed investigators as subordinates Essential Functions Assess the current state of ... and supervise the deviation investigation team, assign deviations based on investigator skill/experience and deviation type, ensure level-loading of investigator … more
- Taiho Oncology (TX)
- …cancer treatment evolves, we evolve with it. Advanced technology, dedicated investigators , and incomparable facilities: these vast resources empower us to redefine ... clinical, scientific and medical information between Key Opinion Leaders (KOLs)/ investigators and the company's Medical Affairs and development groups. Establish,… more
- Merck & Co. (North Wales, PA)
- …deliverables, protocol level plans/timelines, country/site selection, system updates, Investigator Meeting planning, communication plans, preparation of status ... internal/external stakeholders (study team, subsidiary country teams, vendors, committees, investigators , site personnel, etc.) in support of clinical study… more
- Lundbeck (Miami, FL)
- …connects KOLs and external stakeholders internally to serve as advisors, investigators , expert consultants, authors, or evidence generation partners Executes on MSL ... gaps Identifies and facilitates the submission of grant requests and investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships, developing and maintaining strong communication channels. Leads successful investigator and strategic partnership negotiations in accordance with all ... of clinical trials improvement/innovation projects for NACD & Novo Nordisk (eg Investigators and site staff, vendors etc.). Establish and manage senior level… more
- Taiho Oncology (New York, NY)
- …updated clinical, scientific, and medical information between Scientific Leaders (SLs)/ investigators , and the company's Medical Affairs and development groups. ... collaboration with Medical Affairs personnel supports data generation in Investigator -Initiated Trials (IITs) and SL/HCP initiated projects. Facilitates the review… more
- Daiichi Sankyo, Inc. (Nashville, TN)
- …medical informationIdentifying and appropriately facilitating engagement of qualified 1) investigators 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… 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with both internal and external stakeholders including KOLs and Principal Investigators . Relationships Reports to: Vice President, Medical & Science. Work with ... with both internal and external stakeholders including KOLs and Principal Investigators . Essential Functions Support the VP Medical/Scientific Development as the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, Managed Access programs and Collaborative Research to the ... support to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, Managed Access programs and Collaborative Research to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the internal clinical study physicians and physician scientists as well as external investigators is expectedThe CS Group Lead will also ensure the writing of ... ethical and regulatory requirements across regions- Interact with clinical investigators , academic organizations, co-development partners, and strategic outsourcingCS Group… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interfacing with both internal and external stakeholders including KOLs and Principal Investigators . Essential Functions Support the M&S team as the clinical lead ... project level Act as a liaison between the company and clinical site investigators and KOLs Interface with Safety Review Committees and Data Safety Monitoring… more
- Merck & Co. (North Wales, PA)
- …scientific findings, research methodologies-Identification of scientifically and operationally strong investigators who can assist in the development of our ... company's investigational and marketed drugs-Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those… more
- Merck & Co. (Rahway, NJ)
- …scientific findings, research methodologies;Identification of scientifically and operationally strong investigators who can assist in the development of our ... companies investigational and marketed drugs;Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those… more
- Merck & Co. (Rahway, NJ)
- …scientific findings, research methodologiesIdentification of scientifically and operationally strong investigators who can assist in the development of our company's ... investigational and marketed drugsEstablishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related field from an accredited college or university required- Master's Degree preferred Experience Qualifications- 4 or More Years Previous experience with a data ... as modern data catalogs, metadata managers and lineage capabilities. preferred - 4 or More Years Experience with data quality...312.32: IND Safety Reports o FDA Guidance for Clinical Investigators , Sponsors, and IRBs - Adverse Event Reporting to… 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
- 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
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