Country Approval Specialist

Praha
Trvalý pracovní poměr
Plný úvazek

Před 17 dny

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionAt 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, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy;
Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients;
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 start up 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;

Thermo Fisher Scientific

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