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The World Leader In Serving Science
Associate Medical Director – Gastroenterology, Hepatology
Location
Argentina
Posted
96 days ago
Salary
0
Seniority
Lead
Job Description
Associate Medical Director – Gastroenterology, Hepatology
Thermo Fisher Scientific
• Provide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. • Attend and present at investigator and sponsor meetings, providing medical consultation to clients, investigators, and project team members, and support business development activities. • Provide medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR). • Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle. • Ensure tasks delegated to PV are properly executed. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Follow client SOPs/directives and project-specific WPDs for assigned projects. Comply with CRG’s corporate policies and SOPs/WPDs. • Provide medical consultation to team members and answer all study-related medical questions. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. • Provide therapeutic training and protocol training on assigned studies, as requested. • Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies. Discuss all medical concerns with principal investigators and clients raised during the course of a study, using proper medical judgment in interpretation and decision-making regarding clinical situations as they relate to the investigational study. • Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities.
Job Requirements
- MD or equivalent required.
- Active medical licensure preferred.
- Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years).
- Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry.
- Direct experience in safety/Pharmacovigilance (comparable to 2 years).
Benefits
- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations with occasional travel both domestic and international.
- Thermo Fisher Scientific values the health and wellbeing of our employees.
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