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Country Approval Associate
Thermo Fisher Scientific. Prepare, review and coordinate Country Submissions under guidance and in alignment with global submission strategy .
About the role
Key responsibilities & impact- Prepare, review and coordinate Country Submissions under guidance and in alignment with global submission strategy
- Support preparation of local Ministry of Health submissions, as applicable
- Coordinate internal functional departments to align site start-up and submission activities with agreed timelines and site activation critical path
- Achieve company target cycle times for sites
- Communicate with investigators regarding submission-related activities
- Act as a country-level key contact for Ethical or Regulatory submission activities
- Work with start-up CRAs to prepare regulatory compliance review packages
- Assist in developing country-specific Patient Information Sheets and Informed Consent forms
- Assist with grant budgets and payment schedule negotiations with sites
- Enter and maintain trial status information in company or client tracking databases
- Prepare, establish and maintain local country study files and filing processes according to applicable procedures
- Maintain knowledge of PPD and client SOPs/directives and current regulatory guidelines
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 0 to 2 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
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic organizational and planning skills
- Basic knowledge of applicable regional/national country regulatory guidelines and EC regulations
- Equivalency may consist of a combination of appropriate education, training and/or directly related experience
- Ability to work in an office/laboratory and/or clinical environment
- Ability to work with potential exposure to biological fluids, infectious organisms, and electrical office equipment
- Ability to use required personal protective equipment
Benefits
Comp & perks- Collaboration and development opportunities
- Exposure to a global team environment
- Personal protective equipment such as protective eyewear, garments and gloves