FSP Country Approval Specialist

🕒 September 23

🇷🇴 Romania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 Ghost score 16%

What it means: the chance that no one is really hiring for this job.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.

Apply Now

Find Similar Remote Jobs

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 EU/global submission strategy • Provide local regulatory strategy advice to internal clients • Provide project-specific local start-up services and coordinate projects • Contact investigators for submission-related activities as needed • Serve as country-level key contact for ethical or regulatory submission activities • Coordinate internal functional departments to align site start-up activities with submission activities and timelines • Ensure submission processes align with the critical path for site activation • Achieve target cycle times for site activation • Prepare regulatory compliance review packages when applicable • Develop country-specific Patient Information Sheet/Informed Consent Form documents • Assist with grant budget and payment schedule negotiations with sites • Support feasibility activities as required • Enter and maintain trial start-up status information in study tracking databases • Prepare, set up, and maintain local country study files and filing processes according to applicable SOPs • Maintain knowledge of SOPs, client directives, and current regulatory guidelines

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalency may consist of appropriate education, training and/or directly related experience • 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

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume