- 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 ... compliant with regulatory standards5. Compliance and Audit SupportParticipate in internal audits and gap analyses.Support regulatory inspections by providing… more
- Merck & Co. (Salt Lake City, UT)
- …help drive our Strategic Operating Priorities.Invent - Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute - ... activities including our Company sponsored trials and our Company Independent Investigator Study Programs as prioritized and requested by our Research Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …indications/projects related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, ... and other cross-functional and regional stakeholders.Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… more
- Merck & Co. (North Wales, PA)
- …as a member on the Value Evidence sub-team for Gynecologic Cancer internal stakeholders' expectations with timely updatesInteracts with internal stakeholders for ... guidelines and regulatory landscape in the US regionReview of Investigator Initiated StudiesCollaborates and leads interaction with our external collaboration… more
- Eisai, Inc (Austin, TX)
- …teaching-hospital faculty, residents, and students. Provides medical information to internal /external health sources such as the sales force, outside health ... planning. Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials.Serve as primary… more
- Legend Biotech USA, Inc. (Atlanta, GA)
- …scientific meetings including congresses, symposia, advisory boards, and investigator meetings. Interpret and report findings with recommendations for ... action to relevant internal stakeholders.Serve as the primary local point of contact...research staff who may participate in company sponsored and investigator initiated clinical trials.Demonstration of excellent oral presentation and… 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 ... medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …indications/projects related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, ... and other cross-functional and regional stakeholders.- Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in… more
- Daiichi Sankyo, Inc. (Minneapolis, MN)
- …The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (eg, Medical, Marketing, and Sales), and decision makers in ... and study committee members for DSI clinical research programs, 2) investigator -initiated research study proposals, 3) speakers for DSI Brand Speaker programs,… more
- Insmed Incorporated (San Diego, CA)
- …program(s). Responsibilities include but are not limited to: Collaborate with internal teams, contract research organizations (CROs), and external vendors to ... regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator Brochures) Support enrollment projections and assist with the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level as needed The SDL will have regular interactions with key internal and external stakeholders to discuss project status, escalate issues, and troubleshoot ... -Lead the core study team while project managing and collaborating with internal stakeholders to ensure cross functional integration and delivery of study milestones… 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 ... tools and technology platforms to streamline clinical processes. Collaborate with internal and external tech partners to evaluate and implement cutting-edge… more
- Formation Bio (New York, NY)
- …with building a team and maintaining up to date knowledge through internal and external partnership. Responsibilities 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… more
- Insmed Incorporated (NJ)
- …and maintain KPIs, scorecards, and governance frameworks for both internal supply operations and external partnersServe as clinical supply representative ... foster career/talent developmentCreate, review, and update SOPs, pharmacy manuals, Investigator Brochures, and handling guidanceSupport Clinical Supply Chain to… more
- Insmed Incorporated (NJ)
- …in developing the strategy for Independent Medical Education in compliance with internal processes.Provide strategic medical support to Drug Safety for any product ... of data gaps and provide support to the processes related to Investigator Initiated Studies.Work collaboratively with key intra- and inter- departmental partners… more
- Prairie View A&M University (Prairie View, TX)
- …agencies, foundations, and industry partners. Promote research achievements through internal and external channels. Coordinate with Research Communications to ... grant administration. Demonstrated success in leading or supporting large-scale, multi- investigator proposals. Experience working with federal, state, and private… more
- LocumJobsOnline (Miami, FL)
- …Florida, 33137! About The Position JOB OVERVIEW Job Title: Medical Director Internal Medicine Job Type: Permanent Location: Florida - Miami, Ft. Lauderdale, ... and charting compliance Participate in clinical research and serve as Sub- Investigator when needed Lead interdisciplinary team meetings and daily huddles Oversee… more
- Houston Methodist Specialty Care Group (Houston, TX)
- …in GU Medical Oncology. Candidates should be board certified (or board eligible) in Internal Medicine and Medical Oncology by the American Board of Internal ... an established clinical trial support unit to function as a clinician investigator within a collegial, multi-disciplinary group, consisting of GU focused urologists,… more
- UTMB Health (Galveston, TX)
- Equal Opportunity Investigator - Internal Investigations **Galveston, Texas, United States** **New** Legal & Compliance UTMB Health Requisition # 2506625 ... structures. + Performs related duties as required. **Knowledge/Skills/Abilities:** + Competent internal workplace investigator . + Moderate knowledge of Human… more
