- 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
- 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
- Insmed Incorporated (San Diego, CA)
- …projects.Manage and participate in developing and drafting protocols, forms, investigator brochures, clinical study reports and other documents as needed.Manage ... appropriate metrics to assess performance, compliance and cost effectiveness.Leads investigator meetings, kick-off meetings, monitoring training and various CRO (or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.Note that vendor management is not limited to the ... bring deviations to the supervisor. Review and approve Vendor invoices, including investigator grants and pass-through costs.Provide oversight of the CRO to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator 's Brochure (IB), integrated safety summaries, abstracts and planned publications ... by participation in project/trial groups/teams established, as appropriate and conducts Investigator training as required Provide answers to enquiries from HAs 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 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
- Taiho Oncology (TX)
- …In collaboration with Medical Affairs personnel support data generation Investigator -Initiated Trials (IITs) and HCP initiated projects. Facilitate the review ... or PhD) in medical or health sciences is strongly preferred or equivalent. Experience: Three years of experience in...of experience in a field facing scientific role is preferred and MSL experience is preferred . Experience… 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 ... Education and Certifications: BS degree in related engineering/scientific field. MS preferred Certification in Six Sigma or other process improvement methodology is… more
- Merck & Co. (Rahway, NJ)
- …in a timely manner in coordination with the study CRM.Attend local Investigator Meetings if requested to.Interface with GCTO partners on clinical trial ... years' experience as CRA monitoring clinical trialsLine management experience preferred or at the minimum team leader experienceEducational Requirements:Required:Bachelor's… more
- Merck & Co. (Rahway, NJ)
- …trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update ... clinical drug development experience OR PhD/PharmD Degree in life sciences, preferred .Required experience and skills: Solid knowledge of clinical research regulatory… 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
- Eisai, Inc (Nutley, NJ)
- …the pharmaceutical industry and a background in medical affairs is highly preferred . The successful candidate will have advanced written and verbal communication ... advisory boards, health outcomes plans, MSL activities, speaker programs, investigator -initiated research and CME grant reviews or other internal key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documentsAuthors or oversees the development of safety sections of Investigator 's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data ... reasonable accommodation.Education Qualifications (from an accredited college or university)PharmD preferred .PhD preferred .Bachelor's degree in healthcare required.Experience Qualifications:3-5… more
- Daiichi Sankyo, Inc. (Louisville, KY)
- …and study committee members for DSI clinical research programs, 2) investigator -initiated research study proposals, 3) speakers for DSI Brand Speaker programs, ... field or an equivalent combination of education and experience preferred Experience:MSL/Sr. MSLExperience Qualifications:1 or More Years' experience including… 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 ... required.College degree or high school diploma with relevant industry experience is preferred . Previous Supervisory experience is preferred . Good computer skills… more
- Merck & Co. (North Wales, PA)
- …country-specific data supporting pricing and reimbursement Work with our company's Investigator Study Program Committee to evaluate outcomes research study protocols ... thinking skills A track record of scientific presentations and publications - Preferred skills: Good understanding of HTA/reimbursement and market access needs in… more
- Aequor (Thousand Oaks, CA)
- …of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed ... new or supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs, Research,… 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 ... PharmD or PhD) in medical or health sciences is preferred . Knowledge, Skills, and Abilities: A minimum of 3...5 years MSL experience or similarly related experience is preferred . At least 1 year of Oncology MSL experience… more
