Country Approval Specialist - FSP dedicated - EMEA
Country Approval Specialist - FSP dedicated - EMEA
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll 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 PPDs 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
- Bachelors 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;
Required Experience:
Unclear Seniority
Employment Type
Full-Time
