- DivIHN Integration Inc (Columbus, OH)
- …would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF ... completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. 0-3 Years… more
- Dexian - DISYS (Baltimore, MD)
- …duties and group benefit contracts to identify control deficiencies and non- compliance . Investigator will develop documentation to substantiate finding including ... Job Description: Job Duties: The role of the Special Investigations Unit (SIU) Investigator is to assist in the reduction and recuperation of losses through the… more
- Catalent (Philadelphia, PA)
- …for "Good Manufacturing Practices" and "Good Distribution Practices"Act as lead investigator for all compliance issues regarding incoming, distribution, returns, ... management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. They will… more
- Bering Straits Native Corporation (Washington, DC)
- …Straits Native Corporation is currently seeking a qualified Background Investigator for Articom, Washington DC. Responsibilities ESSENTIAL DUTIES & ... Conduct federal background investigations and prepare reports of investigations in compliance with Federal Investigative Standards, all laws, and other required… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to… more
- nTech Solutions, Inc. (Baltimore, MD)
- …and group benefit contracts to identify control deficiencies and non- compliance . Develop documentation to substantiate findings including formal reports, ... spreadsheets, graphs, audit logs, use of anti-fraud software and appropriately sourced reference materials. Ensure audits and investigations are timely, effective and result in an overall achievement of unit goals. Researches and analyzes claims data using… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships, developing and maintaining strong communication channels. Leads successful investigator and strategic partnership negotiations in accordance with all ... make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management: Assessing and mitigating… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with operational deviations and a champion for quality priority principles and compliance within the organization. This is an onsite based role with relocation ... and supervise the deviation investigation team, assign deviations based on investigator skill/experience and deviation type, ensure level-loading of investigator … more
- BioAgilytix (Boston, MA)
- …Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of data and documentation generated by the Bioanalytical Operations ... by the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator )independently creating reports, plans, and submission documents in support of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards ... to team members and track them to completion. Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks. Perform… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 MI&E activities in order… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and ... of coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information collection, processing,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the ... with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgets.Collect… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …CTMS or by other appropriate methods. Routinely identifies methods that facilitate investigator compliance . Maintains information for Adverse Event and External ... and maintenance of required regulatory documents for conducting clinical research in compliance with the Federal Food and Drug Administration (FDA). This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... slide decks, and other internal training resources, within legal and compliance regulations. Provides training or communication of emerging data (internal or… more
- SWCA Environmental Consultants (Austin, TX)
- …or research-oriented supervisory experience can substitute for a portion of compliance -based experience.Experience with and thorough knowledge of NEPA, Section 106, ... offices across the United States, SWCA is one of the largest environmental compliance firms and ranks among Engineering News-Record's Top 200 Environmental Firms. If… more
- Eisai, Inc (Nutley, NJ)
- …expected to be a team player, and an advocate for quality, compliance , professionalism, and core corporate values at Eisai. Essential Functions Conceptualization, ... and vendors, develops and maintains client relationships.As project lead/principal investigator has project budget, deliverable and timeline responsibility; identifies… more
- Lundbeck (Miami, FL)
- …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
- Tris Pharma (Monmouth Junction, NJ)
- …agreements with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities Reviews and/or contributes to ... safety sections of key study documents such as (ie, Investigator Brochures, protocols, statistical analysis plans, informed consent forms, Clinical Study Reports… more
- Insmed Incorporated (Bridgewater, NJ)
- …associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program ... including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD… more
