Senior Country Approval Specialist

🔥 16 minutes ago

🇧🇷 Brazil – 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 guidelines and processes are followed for internal, investigator, and regulatory-authority communications • Act as key country-level contact for submission-related activities • Participate in Submission Team, Review, and Project Team meetings • Coordinate site start-up activities with internal functional departments and align submissions with site activation critical paths • Achieve company target cycle times for site activations • Prepare regulatory compliance review packages • Coordinate local submission activity in accordance with global project submission strategy • Develop country-specific Patient Information Sheet and Informed Consent Form documents • Assist with grant budgets and payment schedule negotiations with sites • Identify local out-of-scope contract activities and advise relevant functions • Support feasibility activities according to agreed timelines • Maintain accurate and current trial status information in the database • Oversee country study files for compliance with PPD WPD or client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives, and current regulatory guidelines • Direct or mentor assigned Start-Up individuals • Proactively identify, resolve, or escalate regulatory process issues

🎯 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 • An equivalency combining appropriate education, training and/or directly related experience may satisfy the role requirements • 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 Start-Up team members • Excellent team player with teambuilding skills • Organizational and planning skills • Knowledge of applicable regional/national country regulatory guidelines and EC regulations

🏖️ Benefits

• Fully Remote work arrangement • Global team environment • Collaboration and development opportunities • Passion, innovation, and scientific excellence culture

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