Country Approval Specialist
Posted 2 days ago
You'll complete your application on Thermo Fisher Scientific's career site.
About the Role
This Country Approval Specialist role focuses on the management and orchestration of key regulatory submission procedures for clinical trials. Serving as a vital member of the clinical operations department, you will ensure that all regulatory tasks are completed accurately to maintain project schedules. You will function in a fast-paced setting as the main liaison for ethical and regulatory concerns within the country, ensuring site start-up operations are performed effectively to aid in the advancement of science and medicine.
Requirements
- You should possess a bachelor's degree or a comparable mix of professional background and education.
- A minimum of two years of related experience is necessary to establish the prerequisite skills for regulatory filings.
- You need exceptional verbal and written communication abilities, as well as a high degree of precision, commitment to document quality, and strong negotiation skills.
- You must have a fundamental grasp of medical concepts, relevant therapeutic areas, and regional regulatory standards.
- You are expected to show strong planning and organizational skills, technical proficiency with software, and the adaptability to operate successfully both individually and within a group.
- You may encounter biological fluids or electrical machinery, requiring the consistent use of personal protective gear.
Responsibilities
- You will draft, examine, and oversee local regulatory applications to ensure they comply with international strategies.
- You will act as the principal representative for regulatory and ethical tasks, offering expert guidance to internal partners and managing site initiation services for specific projects.
- You will partner with internal groups to synchronize site activation schedules with essential project milestones.
- You will reach out to investigators regarding submission needs and create country-specific informed consent and patient documentation.
- You will participate in budget negotiations for grants, oversee trial progress within internal systems, and uphold local study documentation in accordance with standard operating procedures.
- You will assist with feasibility assessments to help reach study objectives.
Note: This listing is summarized and paraphrased by WorkNow from a publicly posted role. For the original wording and full details, please refer to the employer's official posting.
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