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- Tasks: Coordinate regulatory submissions to activate investigative sites and ensure compliance.
- Company: Join Thermo Fisher Scientific, a leader in making the world healthier and safer.
- Benefits: Enjoy a full-time role with opportunities for career growth and impactful work.
- Why this job: Make a difference in global health while developing your skills in a supportive environment.
- Qualifications: Bachelor's degree and 2+ years of relevant experience required.
- Other info: Work standard hours in an office setting, collaborating with diverse teams.
The predicted salary is between 36000 - 60000 £ per year.
Country Approval Specialist – FSP dedicated – EMEA
Join to apply for the Country Approval Specialist – FSP dedicated – EMEA role at Thermo Fisher Scientific
Country Approval Specialist – FSP dedicated – EMEA
1 day ago Be among the first 25 applicants
Join to apply for the Country Approval Specialist – FSP dedicated – EMEA role at Thermo Fisher Scientific
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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Discover Impactful Work:
As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.
A day in the Life:
- Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy;
- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients;
- Provides project specific local SIA services and coordination of these projects;
- May have contact with investigators for submission related activities;
- Key-contact at country level for either Ethical or Regulatory submission-related activities;
- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation;
- Achieves PPD’s target cycle times for site;
- May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable;
- May develop country specific Patient Information Sheet/Informed Consent form documents;
- May assist with grant budgets(s) and payment schedules negotiations with sites;
- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines;
- Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner;
- Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs;
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Education
- Bachelor\’s degree
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Knowledge, Skills, Abilities
- Effective oral and written communication skills;
- Excellent social skills;
- Strong attention to detail and quality of documentation;
- Good negotiation skills;
- Good computer skills and the 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 all applicable regional / national country regulatory guidelines and EC regulations;
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research and Science
-
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Country Approval Specialist - FSP dedicated - EMEA employer: Thermo Fisher Scientific
Contact Detail:
Thermo Fisher Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Country Approval Specialist - FSP dedicated - EMEA
✨Tip Number 1
Familiarise yourself with the regulatory guidelines and submission processes specific to the EMEA region. Understanding local regulations will not only help you in your role but also demonstrate your commitment and expertise during interviews.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience with regulatory submissions. Engaging with industry peers can provide valuable insights and may even lead to referrals for the position.
✨Tip Number 3
Showcase your attention to detail by preparing a mock regulatory submission document. This practical demonstration of your skills can be a great talking point during interviews and highlight your capability to handle the responsibilities of the role.
✨Tip Number 4
Stay updated on the latest trends and changes in clinical trial regulations. Being knowledgeable about current events in the industry will not only prepare you for potential interview questions but also show your enthusiasm for the role.
We think you need these skills to ace Country Approval Specialist - FSP dedicated - EMEA
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience and skills that align with the responsibilities of a Country Approval Specialist. Emphasise your attention to detail, communication skills, and any previous regulatory submission experience.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention specific projects or experiences that demonstrate your ability to manage regulatory submissions and work collaboratively with teams.
Highlight Relevant Skills: In your application, clearly outline your knowledge of regulatory guidelines and your ability to coordinate with various departments. Use examples to illustrate your negotiation skills and attention to detail.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Ensure there are no grammatical errors and that all information is accurate. A polished application reflects your professionalism and attention to detail.
How to prepare for a job interview at Thermo Fisher Scientific
✨Understand the Role
Make sure you thoroughly understand the responsibilities of a Country Approval Specialist. Familiarise yourself with regulatory submissions and the specific requirements for the role, as this will help you answer questions confidently.
✨Showcase Attention to Detail
Since this role requires a strong attention to detail, prepare examples from your past experiences where your meticulousness made a difference. Highlight how you ensure accuracy in documentation and compliance.
✨Demonstrate Communication Skills
Effective communication is key in this position. Be ready to discuss how you've successfully communicated complex information to various stakeholders in previous roles, showcasing both your oral and written skills.
✨Familiarise Yourself with Regulatory Guidelines
Brush up on the relevant regional and national regulatory guidelines that apply to the role. Being knowledgeable about these regulations will not only impress your interviewers but also show your commitment to the field.
