- 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
- 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 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
- 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)
- …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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application summary documents, etc. Research and analyze the ... evolving competitive and regulatory landscapes to maintain current knowledge Effectively manage timelines while working in a fast-paced and dynamic environment across both time zones and cultures Physical Requirements 10-20% overnight travel required. Ability… more
- Tris Pharma (Monmouth Junction, NJ)
- …to safety sections of key study documents such as (ie, Investigator Brochures, protocols, statistical analysis plans, informed consent forms, Clinical Study ... Reports (CSRs), etc.); Provides expert safety guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials Assists in preparation of response to regulatory inquiries related to safety; Prepares… 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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD ... submissions, and responses to questions from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.Production of tables, listings and narratives of safety areas of… 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
- 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
- Rowan College at Burlington County (Mount Laurel, NJ)
- Public Safety Investigator III Print (https://www.schooljobs.com/careers/rcbcedu/jobs/newprint/4396759) Apply Public Safety Investigator III Salary $41,373.48 ... Conduct committee as it relates to investigations. The Public Safety Investigator is responsible for conducting investigations that are pandemic/health related, rise… more
- Rowan College at Burlington County (Mount Laurel, NJ)
- Public Safety Officer- Investigator Sergeant Print (https://www.schooljobs.com/careers/rcbcedu/jobs/newprint/4467049) Apply Public Safety Officer- Investigator ... Conduct committee as it relates to investigations. The Public Safety Investigator is responsible for conducting investigations that are pandemic/health related, rise… more
- MTA (New York, NY)
- Senior Equal Opportunity Investigator Job ID: 4633 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: Date ... and the Director of Investigations, the Senior Equal Opportunity (EO) Investigator partners with Agency management to develop, coordinate, implement, enforce and… more
