- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Sr. Investigator as part of the Technical Operations team based in Raritan, NJ.Role ... OverviewThe CAR-T Sr. Investigator will be part of the Technical Operation team and will be responsible to provide specialist knowledge and expertise of cell and… more
- AUROBINDO (Durham, NC)
- …world to live in.Job OverviewAs a key site Quality Employee the QA Investigator will be responsible for assuring that the investigations are conducted and written ... in compliance with all cGMP regulatory as well as facility requirements. This individual will be responsible for:Leading, conducting, writing, reviewing and approving investigations for Deviations and Market Complaints.Assisting SMEs in root cause analysis and… more
- Merck & Co. (Salt Lake City, UT)
- …activities including our Company sponsored trials and our Company Independent Investigator Study Programs as prioritized and requested by our Research Development ... requested by our Research & Development Division's leadership, including our Company's Investigator Study Program (ISP), by acting as the primary liaison to… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Legend Biotech USA, Inc. (Atlanta, GA)
- …scientific meetings including congresses, symposia, advisory boards, and investigator meetings. Interpret and report findings with recommendations for ... research staff who may participate in company sponsored and investigator initiated clinical trials.Demonstration of excellent oral presentation and communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a US IIS Review Committee, for ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …2 and above may be eligible for consideration as a department investigator . This employee should possess excellent communication and public relations skills. The ... position requires a valid Kansas driver's license. Apply department orders, rules and regulations to police situations; understands and applies legal standards. Operates patrol/unmarked vehicle in a safe and effective manner; inspects vehicle for safe and… more
- Eisai, Inc (Philadelphia, PA)
- …relationship Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials. The MSL ... may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies.REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (eg MD/DO,… more
- Insmed Incorporated (San Diego, CA)
- …regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator Brochures) Support enrollment projections and assist with the development and ... implementation of subject recruitment and retention strategies Provide scientific support to the study teams, including:Collaborate with team members in the review and development of Data Management activities including eCRFs, edit checks, report development,… more
- Daiichi Sankyo, Inc. (Minneapolis, MN)
- …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
- Insmed Incorporated (NJ)
- …clinical studies.Perform medical monitoring, coding, and data cleaning, and prepare Investigator Alert letters and SAE reports in collaboration with Clinical ... Operations.Ensure the medical integrity of clinical study reports and data interpretation/communication.Author or oversee authorship of clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory… more
- Daiichi Sankyo, Inc. (Bernards, 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
- BioAgilytix (Durham, NC)
- …as Bioanalytical Project Manager on a project (BPM)/Principal investigator (PI)May prepare and submit deviationsManage project timelines/schedulingManage budget ... and revenue for projectsCommunicate with clientTrain analysts/junior scientistsDevelop assays independentlyAbility to assist with definition of project scope and proposal preparation (SME)Prepare and review scientific training materials (eg BAL University)Set… more
- Formation Bio (New York, NY)
- …Support protocol development and development of essential documents (eg, Investigator 's Brochures, informed consent forms) by providing critical operational ... insights. Remain current on emerging industry trends, regulatory updates, and best practices, pivoting operational strategies to maintain competitive advantage. AI and Technology Enablement Leverage AI-powered tools and technology platforms to streamline… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Inform Finance of deviations-Review and approve Vendor invoices, including investigator grants and pass through costs.- Quality and inspection readiness-Support ... inspection readiness and quality initiatives pertaining to assigned study(ies).-Serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for… more
- BioAgilytix (San Diego, CA)
- …and prepare SOPs.Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI) for all assigned clients and studies.Lead regularly scheduled ... client meetings to ensure effective communication and manage client expectations.Provide client satisfaction and great science.Achieve corporate revenue targets.Additional ResponsibilitiesOther duties as neededMinimum Preferred Qualifications:… more
- Insmed Incorporated (NJ)
- …foster career/talent developmentCreate, review, and update SOPs, pharmacy manuals, Investigator Brochures, and handling guidanceSupport Clinical Supply Chain to ... ensure compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during inspections, perform risk assessments for supply interruptions and implement and complete mitigation strategiesCollaborate on… more
- Insmed Incorporated (NJ)
- …including but are not limited to protocols and protocol amendments, Investigator 's Brochures (IBs) and IB updates, clinical study reports (CSRs), Clinical ... Summary Modules for Regulatory Submissions, and responses to regulatory authorities. As a content expert, this individual has a significant understanding of regulatory requirements and ICH guidelines (including E3 and E6), and knowledge of document management… more
- Eisai, Inc (Pittsburgh, PA)
- …planning. Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials.Serve as primary ... contact to external investigators who submit IISs. The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored post-marketing studies. Professional Organization Support… more
- Formation Bio (New York, NY)
- …Oversee GXP, Data Integrity, and CSV activities across various entities, investigator sites, research organizations, clinical and nonclinical studies, PV vendors, ... and CDMOs. Maintain efficient systems and processes that ensure Formation Bio and its vendor network comply with GXP, and Computer validation standards. Provide leadership and direction to the quality assurance team, ensuring that all quality activities are… more
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