Medical Director – Sleep Disorders

🔥 42 minutes ago

🌐 Argentina, Brazil, +3 more countries – Remote

🇦🇷 Argentina – Remote 🇧🇷 Brazil – Remote 🇨🇴 Colombia – Remote 🇵🇪 Peru – Remote 🇨🇱 Chile – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle • Ensure delegated pharmacovigilance tasks are properly executed and comply with regulations, ICH guidelines, client directives, and company SOPs/WPDs • Provide medical consultation to team members and answer study-related medical questions • Communicate with associates and clients to ensure procedures are followed appropriately • 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, CTD modules, and related deliverables • Monitor safety variables in clinical studies, including adverse events, laboratory abnormalities, patient medical status, concomitant medications, and un-blinding requests • Discuss medical concerns with principal investigators and clients and apply medical judgment to clinical situations • Review adverse events of special interest, serious adverse events, and clinical outcomes events • Perform contracted data review and validation to assess potential safety concerns • Manage signal detection activities and 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

• Medical Doctor with a specialty in Neurology focused on Sleep disorders • Clinical experience treating patients with Sleep disorders in hospital practice • At least one of: clinical experience in the relevant specialty/sub-specialty comparable to 2 years; suitable clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator comparable to 1–2 years; direct safety/Pharmacovigilance experience comparable to 2 years • Significant experience within the pharmaceutical industry, clinical trials, and pharmaceutical medicine • Solid experience with PIPs (pediatric investigation plans) • Fluent in spoken and written English • Understanding and experience with the NDA submission process • Understanding of regulatory guidelines for adverse event reporting • Strong communication and presentation skills • In some cases, an equivalency consisting of appropriate education, training and/or directly related experience may be considered sufficient

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Meaningful work contributing to healthier, cleaner, and safer outcomes • Resources to achieve individual career goals • Opportunity to contribute to scientific innovation and life-changing therapies

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