Country Approval Associate

Thermo Fisher Scientific•Morrisville, NC

1d•Onsite

About The Position

The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission strategy. This role involves preparing and reviewing local submissions, coordinating with internal departments for site start-up activities, and ensuring alignment with submission timelines. The associate may interact with investigators and act as a country-level contact for submission-related activities. Additionally, the role involves preparing regulatory compliance packages, assisting with patient information and consent forms, and managing grant budgets and payment schedules. Maintaining trial status information and ensuring proper country study file maintenance are also key responsibilities. The associate must stay knowledgeable about PPD SOPs, client SOPs/directives, and current regulatory guidelines.

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Effective oral and written communication skills
Excellent interpersonal 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.

Responsibilities

Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy.
Support preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.
Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieve company’s target cycle times for site.
May have contact with investigators for submission related activities.
May act as a key-contact at country level for either Ethical or Regulatory submission-related activities.
Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
Assist in developing country specific Patient Information Sheet/Informed Consent form documents.
Assist with grant budgets(s) and payment schedules negotiations with sites.
Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) tracking databases in an accurate and timely manner.
Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.