- Merck & Co. (Rahway, NJ)
- …prepare our Company's teams for meetings with FDA at any phase of drug developmentLead cross-functional efforts to prepare for advisory committees and may speak at ... final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our Company to external agencies… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …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 trialsDemonstration of excellent oral presentation and communication… more
- Merck & Co. (South San Francisco, CA)
- …definitive/Good Laboratory Practice (GLP)], serving as a contributing scientist/principal investigator on toxicity studies, and executing PK/TK strategies to support ... for all TK-related issues pertinent to the development of assigned drug candidates and closely interact with toxicology study directors, project representatives,… more
- Eisai, Inc (Austin, TX)
- …planning. Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials.Serve as primary ... Oncology/Hematology.Strong broad-based scientific and pharmaceutical knowledge.Clinical trial development and drug launch experience is strongly preferred.Knowledge of treatment guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect… more
- Merck & Co. (Rahway, NJ)
- …establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).-- Responsible for authoring clinical supply ... well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols. - Support the collection of clinical suppl… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Taiho Oncology (FL)
- …as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical affairs plans to develop and align the ... In collaboration with Medical Affairs personnel support data generation Investigator -Initiated Trials (IITs) and HCP initiated projects. Facilitate the review… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... needs based on projected project needsMay serve as principal investigator on a projectMay prepare and submit deviationsManage project timelines/schedulingManage… 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 ... broad-based scientific and pharmaceutical knowledge Clinical trial development and drug launch experience is strongly preferred Knowledge of treatment guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg, Project Team, Alliance, Ad hoc, Steering committee, Ad board, workshops, Investigator & Governance meetings). This includes, but is not limited to, the ... experience as a project administrator or similar role in a pharmaceutical drug development environment required Travel:Ability to travel up to 5% Daiichi Sankyo,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents, in ... relevant DSI stakeholders on the disease area, competitive landscape, and compound/ drug . May serve as speaker for program/ franchise medical/scientific training in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teams to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials and managed access programs to the highest quality ... government and local agenciesExpert knowledge required for the end-to-end Drug development process in R&D spaceStrong therapeutic experience specifically Oncology… more
- Tris Pharma (Monmouth Junction, NJ)
- …Drug Applications (NDAs), study protocols, clinical study reports, investigator brochures, regulatory submissions, etc.Ensures accuracy, clarity and consistency ... of scientific content in all documentsCollaborates with clinical researchers, biostatisticians and other stakeholders to gather and interpret dataContributes to research protocol and amendment developmentSupports regulatory submissions by preparing… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Senior Investigator of Deviations Management for Drug Product Finished Goods (DPFG) is responsible to complete major and complex ... North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.… more
- Stony Brook University (Stony Brook, NY)
- …to ensure compliance with federal regulations for institutionally or Principal Investigator (PI)-held Investigational New Drug (IND) and Investigational Device ... Investigator Initiated Trial Specialist - Clinical Trials **Position...three (3) professional references. + Successfully complete a 4-panel drug screen * + Meet Regulatory Requirements for pre-employment… more
- IQVIA (Durham, NC)
- …preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical ... Medical Director activities Clinical Activities: . Interacts with clients regarding drug development programs, study design and protocol . Reviews and provides… more
- Sumitomo Pharma (Phoenix, AZ)
- …those intended for regulatory submission. For example, clinical study reports (CSRs), investigator brochures (IB), new drug application (NDA) common technical ... scientist with strengths in clinical pharmacology, and a working knowledge of drug metabolism and bioanalytic chemistry. This position will report to Senior Director… more
- Stanford University (Stanford, CA)
- …study document to ensure ongoing regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to ... 2-4 years clinical research coordinator experience on industry sponsored and investigator initiated interventional drug /device clinical trials. + Clinical… more
- Capital One (Richmond, VA)
- AML Sr. Investigator I - Special Investigations Unit **AML Sr. Investigator I - Special Investigations Unit** The Anti-Money Laundering (AML) Sr. Investigator ... activity investigations or other AML processes. The AML Sr Investigator I will work closely with AML Supervisors and...federal, state, and local laws. Capital One promotes a drug -free workplace. Capital One will consider for employment qualified… more
