Medical Director – Sleep Disorders

Thermo Fisher Scientific

. Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle .

Posted 11/10/2026full-timeRemote • Argentina, Brazil, Colombia, Peru, ChileLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing pharmacovigilance tasks and medical aspects of clinical trials, with a strong focus on safety monitoring and regulatory compliance. Proficient in providing medical consultation and training, as well as reviewing critical clinical documents and reports.

Highest-signal resume keywords

Medical DoctorPharmacovigilance ExperienceClinical Trial ExperienceNeurology SpecialtyRegulatory Guidelines Understanding

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Applicant Tracking System Keywords

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Hard Skills

Clinical ExperienceAdverse Event ReportingSignal DetectionData Review and ValidationNDA Submission ProcessCSRs Writing and ReviewingPeriodic ReportsRisk Management ActivitiesTherapeutic TrainingPediatric Investigation Plans

Soft Skills

Strong Communication SkillsPresentation Skills

Industry Keywords

Pharmaceutical IndustryClinical TrialsPharmaceutical MedicineICH GuidelinesSOPs/WPDsClinical OutcomesSerious Adverse EventsPatient Medical StatusConcomitant MedicationsLabel Updates

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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