FSP Country Approval Associate

Thermo Fisher Scientific•Wilmington, NC

About The Position

The Country Approval Associate supports the preparation, review, and coordination of Country Submissions in line with the global submission strategy. The role works under guidance to coordinate ethical committee (EC) and, where applicable, Ministry of Health (MoH) submissions, and to align country submission activities with site start-up timelines and the critical path for site activation. The associate may contact investigators and may serve as a country-level key contact for ethical or regulatory submission activities. The role also supports regulatory compliance review packages, country-specific Patient Information Sheets and Informed Consent Forms, site grant budgets and payment schedules, trial status tracking, and the preparation and maintenance of local study files. The associate is expected to follow applicable company and client procedures, directives, and regulatory guidelines. Work is performed in an office, laboratory, and/or clinical environment. Conditions may include exposure to biological fluids and potentially infectious organisms, as well as electrical office equipment. Personal protective equipment, such as protective eyewear, garments, and gloves, may be 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 0–2 years.
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 or therapeutic-area knowledge and medical terminology.
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 EC regulations.

Responsibilities

Prepare, review, and coordinate local EC submissions under guidance and in alignment with the global submission strategy.
Support preparation of local MoH submissions, as applicable, under guidance and in alignment with the global submission strategy.
Coordinate with internal functional departments to align site start-up activities with submission activities and mutually agreed timelines, and ensure submission processes for sites and studies align with the critical path for site activation.
Achieve the company’s target cycle times for sites.
Contact investigators for submission-related activities, as needed.
May act as a country-level key contact for ethical or regulatory submission-related activities.
Work with start-up CRAs to prepare regulatory compliance review packages, as applicable.
Assist in developing country-specific Patient Information Sheets and Informed Consent Forms.
Assist with grant budgets and payment schedule negotiations with sites.
Enter and maintain trial status information for SIA activities in company or client tracking databases accurately and in a timely manner.
Prepare, set up, and maintain local country study files and filing processes according to PPD WPDs or applicable client SOPs.
Maintain knowledge of and understand PPD SOPs, client SOPs and directives, and applicable current regulatory guidelines.