Scientific Affairs Senior

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

The Medical Scientific Reviewer will support the Medical and Scientific Affairs Team by managing the review processes within the Clinical Sequencing Division (CSD) at Thermo Fisher Scientific. CSD enables Precision Medicine worldwide by delivering effective sequencing solutions for clinical and translational research. As we expand, we support clinical validity studies and generate evidence at both local and global levels. Our goal is to advance molecular diagnostics by improving understanding and communication in this rapidly evolving field. The candidate will play a key role in reviewing scientific and medical documents, ensuring regulatory compliance, handling contracts, and applying oncology expertise to support product development and commercialization.

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• Document Review Management: Conduct detailed reviews of scientific, medical, and promotional documents. Ensure consistency, scientific accuracy, and compliance with regulations and guidelines.
• Regulatory/Legal Compliance: Act as the point of contact for regulatory and legal teams. Ensure all documents and processes meet requirements (e.g., Sunshine Act, MedTech Code) and comply with diagnostic standards, especially in oncology.
• Scientific Expertise (Oncology/Pathology): Apply medical or related field knowledge to review and interpret clinical data, research findings, and diagnostic information. Ensure scientific accuracy and relevance.
• Contract Management: Manage contracts by reviewing, negotiating, and ensuring legal and regulatory compliance. Collaborate with internal teams to ensure timely and accurate contract execution related to research, clinical studies, and partnerships.
• Quality Assurance: Participate in quality assurance activities. Review protocols, clinical study reports, scientific papers, and contracts for accuracy and adherence to regulatory guidelines.
• Process Improvement: Identify areas for improvement in the review process. Develop and implement strategies to boost efficiency while maintaining high-quality standards.

• Bachelor's or advanced degree in Oncology, Molecular Biology, Biochemistry, or a closely related field.
• Experience in medical/scientific review, global regulatory compliance, and contract management within diagnostics or pharmaceuticals.
• Strong knowledge of oncology diagnostics and related scientific principles.
• Proficiency in contract review and management in a scientific or medical setting.
• Ability to thrive in a fast-paced, multidisciplinary environment, with excellent attention to detail.