FSP Country Approval Associate

Thermo Fisher Scientific•Wilmington, NC

3d•Onsite

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 supports local Ethics Committee (EC) and Ministry of Health submissions, coordinates submission-related activities with internal functions and sites, and helps ensure site start-up activities align with agreed 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 position 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 setup and maintenance of country study files. The associate is expected to follow applicable company and client procedures and current regulatory guidelines. Work is performed in an office, laboratory, and/or clinical environment.

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; an appropriate combination of education, training, and/or directly related experience may be accepted as an equivalency.
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 or national country regulatory guidelines and Ethics Committee regulations.

Responsibilities

Prepare, review, and coordinate local Ethics Committee submissions under guidance and in alignment with the global submission strategy.
Support preparation of local Ministry of Health 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, keeping the submission process aligned with the critical path for site activation.
Achieve the company's target cycle times for sites.
Contact investigators regarding 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 related to SIA activities in company or client tracking databases accurately and promptly.
Prepare, set up, and maintain local country study files and filing processes in accordance with PPD work practice documents or applicable client SOPs.
Maintain knowledge of and comply with applicable PPD SOPs, client SOPs and directives, and current regulatory guidelines.