Senior Country Approval Specialist
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Job Description
Senior Country Approval Specialist coordinating regulatory submissions and site activation for Thermo Fisher Scientific’s clinical research services. Advising teams and authorities across Australia.
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 in collaboration with internal departments
- Serve as primary contact for investigators and local regulatory authorities
- Ensure submission 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 and submission timelines
- Achieve company target cycle times for site activations
- Prepare regulatory compliance review packages
- Coordinate local submission activity in accordance with global project strategy
- Develop country-specific Patient Information Sheets and Informed Consent Forms
- Assist with grant budgets and site payment schedule negotiations
- Identify 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 and ensure compliance with PPD WPD or client SOPs
- Maintain knowledge of PPD SOPs, client SOPs/directives, and current regulatory guidelines
- Direct or mentor SIA team members assigned to projects
- Identify, resolve, or escalate regulatory process issues and anomalies
Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification
- 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job
- Combination of appropriate education, training, and/or directly related experience may be considered equivalent
- 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
- 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
- Excellent team player with teambuilding skills
- Excellent knowledge of applicable regional/national regulatory guidelines and EC regulations
Benefits:
- Comprehensive health and wellbeing benefits
- Wellness programs
- Employee Assistance Program providing confidential personal and work-related support
- Flexible work arrangements
- Generous leave policies
- Option to purchase additional leave
- Paid birthday leave
- Company-paid parental leave
- Paid volunteer time for charitable organizations
- Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning
- Workshops and mentorship programs
- Learning and skill development opportunities
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