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Medical Director – Sleep Disorders

🕒 February 11

🌐 Serbia, Romania, +9 more countries – Remote

infoinfo

⏰ Full Time

🔴 Lead

👨‍⚕️ 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 February 11

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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

• Provide medical support and medical advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department • Provide medical leadership to study teams, including creating clinical trial protocols and implementing the latest scientific information • Contribute to site selection and review and approve study protocols, amendments, Clinical Study Reports, Informed Consent Forms, Case Report Forms, protocol deviation decisions, and other clinical documents • Conduct real-time medical monitoring of clinical studies, ensuring medical validity of primary endpoints and subject safety • Identify medical issues early and address customer concerns and corrective actions with the Global Medical Indication Lead • Consult internal groups on procedural and budgetary items and protocol amendments • Coordinate internal functions to close gaps and resolve issues • Serve as chief liaison between the sponsor and PPD internal departments throughout study phases • Educate investigator sites through protocol-specific lab procedure presentations and demonstrations • Manage day-to-day clinical trial activities, resolve issues, and answer queries • Act as medical point of contact for internal and external stakeholders, investigators, IRBs, and Health Authorities • Prepare and present materials to study executives and independent safety committees when applicable • Deliver medical training to site staff and CRA training in new indications • Ensure compliance with relevant SOPs and GCP • Collaborate with cross-functional study teams to clarify medical risks, issues, and results

🎯 Requirements

• Medical Doctor, with a specialty in Neurology with focus in Sleep disorders • Shown clinical experience running patients with Sleep disorders in hospital practice • Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine • Solid experience with PIPs (pediatric investigation plan) • Fluent in spoken and written English • Shown understanding and experience with NDA submission process • Shown understanding of regulatory guidelines for adverse event reporting • Strong communication and presentation skills • Strong teammate

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