Senior Country Approval Specialist

🕒 September 22

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 and provide technical expertise and coordination oversight • 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, review and project team meetings • Coordinate site start-up activities with internal functional departments and align submission timelines 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/Informed Consent 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 • 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 individuals 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 • Equivalent combinations of appropriate education, training and/or directly related experience may be considered • 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 • Excellent team player with teambuilding skills • Basic organizational and planning skills • Excellent knowledge of applicable regional/national country regulatory guidelines and EC regulations • Ability to work in an office/laboratory and/or clinical environment • Ability to use required personal protective equipment, including protective eyewear, garments and gloves

🏖️ Benefits

• Collaboration and development opportunities • Passion, innovation, and commitment to scientific excellence • Work in a global team environment