Senior Medical Director – Medical Monitor

🔥 11 minutes ago

🇲🇾 Malaysia – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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 compliance with company SOPs, client directives, good clinical practice, and regulatory requirements • Attend and present at investigator and sponsor meetings • Provide medical consultation to clients, investigators, and project team members • Support business development activities • Manage medical aspects of contracted tasks across the pharmaceutical product life cycle • Ensure tasks delegated to Pharmacovigilance are properly executed • Follow applicable regulations, ICH guidelines, client SOPs/directives, project WPDs, and corporate policies • Answer study-related medical questions and maintain clear communication with associates and clients • Provide therapeutic and protocol training • Write or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules • Contribute to departmental process improvement initiatives • Monitor safety variables 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-study decisions • Medically review adverse events of special interest, serious adverse events, and clinical outcome events • Perform contracted data review and validation, including coding listings and full safety data review • Manage signal detection activities and generate aggregate reports for marketed products • Contribute to label updates, dossier maintenance, and risk-management activities • Review adverse-event and serious-adverse-event data from solicited, spontaneous, and literature sources • Serve as a consultant or spokesperson for the functional area and create formal networks with key decision makers

🎯 Requirements

• MD or equivalent required • Active medical licensure preferred • Clinical experience treating patients in hemato-oncology or a related subspecialty, comparable to 2 years • One of the following: 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 • Broad expertise or unique knowledge relevant to company objectives and principles • Ability to develop solutions to highly complex and unique issues impacting future concepts, products, or technologies

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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