Medical Director – Rheumatology

🔥 2 hours ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 2 hours ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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 • Provide medical consultation to clients, investigators, project team members, and associates • Support business development activities • Provide medical review and analysis for clinical trial serious adverse events, marketed-product ICSRs, periodic safety reports, and other client deliverables • Ensure Pharmacovigilance-delegated tasks are properly executed • Follow applicable regulations, ICH guidelines, client SOPs/directives, project-specific WPDs, and corporate policies • Provide medical consultation and answer study-related medical questions • Provide therapeutic and protocol training on assigned studies • Assist in writing and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules • Monitor safety variables including adverse events, laboratory abnormalities, changes in patient medical status, concomitant medications, and unblinding requests • Discuss medical concerns with principal investigators and clients and interpret clinical situations related to investigational studies • Review adverse events of special interest, serious adverse events, and clinical outcomes reported by study sites • Perform data review, including coding-listing and full-safety-data review, to assess potential safety concerns • Manage signal detection activities and scientifically review aggregate reports • Contribute to label updates, dossier maintenance, and risk-management activities • Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, and literature sources

🎯 Requirements

• MD or equivalent required • Active medical licensure preferred • Clinical experience in rheumatology or an associated specialty/sub-specialty, comparable to 2 years • Or suitable clinical trial experience in a contract research organization, pharmaceutical company, or as a principal investigator, comparable to 1–2 years • Or direct safety/Pharmacovigilance experience, comparable to 2 years • For Senior Medical Director: clinical experience comparable to 2 years plus suitable clinical trial experience comparable to 1–2 years or direct safety/Pharmacovigilance experience comparable to 2 years • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Therapeutic expertise across one or more medical specialties or sub-specialties • Strong decision-making, problem-solving, organizational, and analytical skills • Excellent oral and written communication skills • Working knowledge of relevant safety databases, such as MedDRA • Flexibility to travel domestically and internationally • Ability to work independently and analyze and prioritize sensitive, complex information • Proficiency in basic computer applications • Fluent spoken and written English • Excellent interpersonal, influencing, and team-building skills • Understanding of FDA, ICH, EMA, and GCP guidelines • Working knowledge of biostatistics, data management, and clinical operations procedures • Ability to mentor and train other Pharmacovigilance staff

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Opportunities to support meaningful work improving health outcomes • Occasional domestic and international travel • Healthy and balanced work environment support • Mentoring and training opportunities

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