Senior Country Approval Specialist
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Job Description
Senior Country Approval Specialist coordinating clinical-trial regulatory submissions for Thermo Fisher Scientific. Managing country strategies, authorities, site activation timelines, and compliance documentation.
Responsibilities:
- Prepare, review, and coordinate local regulatory submissions in alignment with global submission strategy
- Provide local regulatory strategy advice to internal clients
- Develop and implement local submission strategy
- Provide technical expertise and coordination oversight for projects
- Serve as primary contact for investigators and local regulatory authorities
- Ensure regulatory guidelines, processes, and communications are followed
- Act as country-level key contact for submission-related activities
- Participate in submission, review, and project team meetings
- Coordinate site start-up activities with internal functional departments
- Achieve target cycle times for site activations
- Prepare regulatory compliance review packages
- Coordinate local submission activity with global project submission strategy
- Develop country-specific Patient Information Sheets and Informed Consent forms
- Assist with grant budgets and payment schedule negotiations
- Identify local out-of-scope contract activities and advise relevant functions
- Support feasibility activities
- Maintain accurate and current trial status information in the database
- Oversee country study files for SOP compliance
- Maintain knowledge of company, client, and regulatory requirements
- Direct or mentor SIA team members
- Identify, resolve, or escalate regulatory process issues
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 5+ years
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good computer skills and ability to learn appropriate software
- Good English language and grammar skills
- Good judgment and decision-making skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, with minimal supervision
- Ability to mentor fellow SIA team members
- Basic organizational and planning skills
- Excellent knowledge of applicable regional/national regulatory guidelines and EC regulations
- Equivalency through a combination of appropriate education, training, and directly related experience may be considered
Benefits:
- Fully remote work
- Standard Office Hours (40/wk)
- Global team collaboration and development opportunities
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