Senior Country Approval Specialist

🔥 0 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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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