FSP Country Approval Specialist

Thermo Fisher Scientific•Wilmington, NC

3d•Onsite

About The Position

The Country Approval Specialist participates in the management, preparation, review, and coordination of country submissions in line with the global submission strategy. Under guidance, the specialist prepares and coordinates local regulatory submissions and provides local regulatory strategy advice to internal clients. The role also supports country-level site start-up and submission activities, maintains study information and files, and follows applicable company and client procedures and regulatory guidelines. Work is scheduled Monday through Friday in an office, laboratory, and/or clinical environment. The position may involve exposure to biological fluids and potentially infectious organisms, as well as electrical office equipment; personal protective equipment such as protective eyewear, garments, and gloves is required.

Requirements

Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2+ years; an appropriate combination of education, training, and/or directly related experience may be considered equivalent.
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 and national country regulatory guidelines and Ethics Committee regulations.

Responsibilities

Prepare, review, and coordinate local regulatory submissions, including Ministry of Health, Ethics Committee, and applicable special national applications, in alignment with the global submission strategy.
Provide local regulatory strategy advice concerning Ministry of Health and/or Ethics Committee submissions to internal clients, under guidance.
Provide and coordinate project-specific local SIA services.
Communicate with investigators about submission-related activities as needed.
Serve as the country-level key contact for Ethical or Regulatory submission-related activities.
Coordinate with internal functional departments, under guidance, to align site start-up activities with submission activities and agreed timelines, and ensure alignment with the critical path for site activation.
Achieve PPD’s target cycle times for site activities.
Work with start-up CRAs to prepare regulatory compliance review packages, as applicable.
Develop country-specific Patient Information Sheet/Informed Consent form documents, as needed.
Assist with grant budgets and payment-schedule negotiations with sites, as needed.
Support coordination of feasibility activities in accordance with agreed timelines.
Enter and maintain trial-status information relating to SIA activities in PPD tracking databases accurately and promptly.
Ensure local country study files and filing processes are prepared, established, and maintained according to PPD WPDs or applicable client SOPs.
Maintain knowledge of and understand PPD SOPs, client SOPs/directives, and current regulatory guidelines applicable to the services provided.