- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team ... based in Raritan, NJ. Role OverviewThe CAR-T Compliance Auditor (Sr. Investigator ) will be a key member of the Technical Operations team, responsible for… more
- Merck & Co. (Cincinnati, OH)
- …activities including our Company's sponsored trials and our Company's Independent Investigator Study Programs as prioritized and requested by Research and ... when requested by Research and Development (R&D) leadership, including our Company's Investigator Study Program (MISP), by acting as the primary liaison to… 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 ... communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a Global IIS Review Committee, for the ... communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the ... Management:Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and other local… more
- Merck & Co. (Buffalo, NY)
- …and goals for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The RMSD serves as a role model for ... the comprehension of the scientific foundations and goals of investigator -sponsored researchIdentifies barriers to patient enrollment and retention efforts to… more
- Merck & Co. (North Wales, PA)
- …local data generation study concepts and protocols when requested. Reviews Investigator -Initiated Study proposals from key countries prior to headquarters submission ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- BioAgilytix (Durham, NC)
- …a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies-including project scope ... future of healthcare.Essential Responsibilities:Serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies including… more
- Eisai, Inc (Nutley, NJ)
- …planning. Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials.Serve as primary ... Affairs Department and Eisai organization, including as it pertains to compliance with policies, systems and practices.Sound computer skills including applications… more
- Lundbeck (Boston, MA)
- …gaps Identifies and facilitates the submission of grant requests and investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request, ... training, documentation, expense reporting, and other administrative responsibilities Ensures compliance with all FDA and Lundbeck requirements Required Education,… more
- Genmab (NJ)
- …the primary point of contact and facilitator for all aspects of investigator sponsored trials (ISTs), from submission, review and approval, through study ... organize, prioritize, and work effectively in a constantly changing environmentStrong compliance knowledge and adherence to corporate compliance policiesCurrent… 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 ... such as scientific symposium and medical congresses, within legal and compliance regulations.- Collaborates across functions to support GMA MIE activities in… more
- AHU Technologies, Inc. (Washington, DC)
- Role: Contract Investigator Location : WASHINGTON, DC (hybrid - 2 days onsite) Client : - DC Government Experience : 5 Years Job Description Onsite 2-3 per week. ... statements, and applies associated internal policies to assess regulatory compliance . 3. Communicates with license Applicants and conducts interviews pertaining… more
- Eisai, Inc (Nutley, NJ)
- …relationship Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials. The MSL ... work independently and not require close supervision while adhering to compliance /regulatory policies. Interest in leading and participating in projects while… more
- RELI GROUP INC (Baltimore, MD)
- …Negotiation Program requirements Assist in the development of all necessary compliance requirements to inform compliance , investigations, reporting, and market ... intake, triage, and prioritization of investigative matters aligned with CMS compliance objectives Collaborate with data analysts, auditors, compliance officers,… 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… more
- DERMCARE MANAGEMENT LLC (Boca Raton, FL)
- …Complete training and ensure adherence of GCPs, SOPs, IATA, and HIPPA Ensure compliance with all clinical trial protocols Ensure compliance with Standard ... into Electronic Data Capture (EDC) data queries are resolved Participate in Investigator meetings and trainings during the course of the trial Generate PowerPoint… more
- Kenai Therapeutics (San Diego, CA)
- …critical clinical documents, including study protocols, clinical study reports, investigator brochures, and safety monitoring plans. Resource and Vendor Management: ... management on the status of ongoing clinical programs and trials. Regulatory Compliance & Safety: Ensure that all clinical trials comply with applicable regulatory… more
- ProTouch Staffing (Long Beach, CA)
- …while maintaining a flexible schedule. You will serve as a Principal Investigator (PI) or Sub- Investigator (Sub-I), overseeing clinical trial activities and ... ensuring the highest standards of patient safety and protocol compliance across Phase I-IV studies.Key ResponsibilitiesServe as PI or Sub-I across clinical trials in… more
- Translational Research in Oncology (Los Angeles, CA)
- …handling, storage, dispensation, tracking and accountability, and destruction/return) Perform Investigator Study File reconciliation: request any new or updated ... and review them for content, consistency with other documents, and compliance with local regulatory requirements, ICH-GCPs guidelines, SOPs Respond to requests… more
