Senior Medical Director, Medical Monitor

🔥 1 hour ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ 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

• Provide medical oversight of clinical trials to ensure compliance with company SOPs, client directives, good clinical practice, and regulatory requirements • Manage all medical aspects of contracted tasks across the pharmaceutical product life cycle • Ensure tasks delegated to Pharmacovigilance are properly executed • Adhere to applicable regulations, ICH guidelines, client SOPs/directives, project-specific WPDs, and corporate policies • Provide medical consultation to team members 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, CTD modules, and related documents • 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 support clinical decision-making • Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events • Perform contracted data review and validation, including coding listings and/or full safety data • Manage signal detection activities and generate aggregate reports • Contribute to label updates, dossier maintenance, and risk management activities • Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources • Attend and present at investigator and sponsor meetings • Provide medical consultation to clients, investigators, and project team members • Support business development activities

🎯 Requirements

• MD or equivalent required • Active medical licensure preferred • Clinical experience treating patients in hema oncology or a related sub-specialty, comparable to 2 years • Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator, comparable to 1–2 years; or direct experience in safety/Pharmacovigilance, comparable to 2 years • Broad expertise or unique knowledge in the functional area • Ability to develop solutions to highly complex and unique issues • Ability to exercise independent judgment in methods, techniques, and evaluation criteria • Ability to serve as a consultant and spokesperson on highly significant matters • Ability to create formal networks with key decision makers

🏖️ Benefits

• Fully remote work arrangement • Full-time employment