Associate Medical Director - Rheumatology

October 29

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. • Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. • Provides 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). • Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle. • Ensures tasks delegated to medical monitoring are properly executed. • Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. • Provides medical consultation to team members and answers all study-related medical questions. • Provides therapeutic training and protocol training on assigned studies as requested. • Discusses all medical concerns with principal investigators and clients raised during the course of a study, using proper medical judgment in the interpretation and decision-making with regard to clinical situations as they relate to the investigational study.

Requirements

• MD or equivalent required. • Active medical licensure preferred. • Clinical experience in treating patients in the speciality or sub-speciality 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) • Qualified candidates should have a background as a Rheumatologist. • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. • Therapeutic expertise across one or more medical specialty or sub-specialties. • Strong decision-making, problem solving, organizational skills and analytical skills. • Excellent oral and written communication skills. • Flexibility to travel domestically and internationally. • Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information. • Proficiency in basic computer applications. • Fluent in spoken and written English. • Excellent interpersonal, influencing and team building skills.