Medical Scientific Reviewer
1 settimana fa
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
Are you ready to take your career in Medical Affairs to the next level? Thermo Fisher Scientific Inc. is seeking a highly motivated and experienced Medical Scientific Reviewer to join our outstanding team.
We are dedicated to enabling our customers to make the world healthier, cleaner, and safer. As one of the global leaders in the industry, we strive for flawless execution and world-class innovation. This is the perfect opportunity for a proven professional to showcase their expertise and make a significant impact in the field of medical research.
The job involves assisting the Medical and Scientific Affairs Team with review processes and activities in the Clinical Sequencing business. We are working towards enabling Precision Medicine globally by providing effective sequencing solutions for clinical and translational research. Our goal is to expand our clinical reach through supporting studies and generating evidence in the molecular diagnostics field.
**Key Responsibilities**:
- Conduct detailed reviews of scientific, medical, and promotional documents to ensure consistency, scientific validity, and compliance with regulations and guidelines.
- Collaborate with regulatory and legal teams to ensure compliance with applicable requirements and international standards for diagnostics, including oncology.
- Contract Management: Supervise the management of contracts, including reviewing, negotiating, and ensuring compliance with requirements.
- Quality Assurance: Participate in quality assurance activities, including reviewing protocols, clinical study reports, scientific papers, and contracts for accuracy and adherence to regulatory guidelines.
- Cross-Functional Teamwork: Collaborate with all internal partners to ensure scientific, regulatory, and contractual alignment.
- Process Improvement: Identify areas for improvement in the review and contracting process, developing and implementing strategies to increase efficiency while maintaining quality standards.
**Minimum Requirements/Qualifications**:
- Bachelor's or advanced degree in a health-related field such as Oncology, Molecular Biology, Biochemistry, or a closely related field.
- Minimum of 3 years of experience in medical/scientific review, regulatory compliance, and contract management within the diagnostics or pharmaceutical industry.
- In-depth knowledge of oncology diagnostics and related scientific principles.
- Familiarity with global regulatory requirements (FDA, EMA, etc.).
- Experience in contract review and management within a scientific or medical setting.
- Proficiency in medical writing and document management systems is a plus.
- Familiarity with software tools for document submission and review, as well as contract management software.
- Excellent attention to detail and ability to handle complex scientific data.
- Ability to work collaboratively in a fast-paced, multidisciplinary environment.
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