Job Description :
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Join Us as a Country Approval Associate - Make an Impact at the Forefront of Innovation
The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission strategy.
What You'll Do:
. 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.
Education & Experience 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.
Knowledge, Skills, Abilities:
. 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.
Working Conditions and Environment:
. Work is performed in an office/ laboratory and/or a clinical environment.
. Exposure to biological fluids with potential exposure to infectious organisms.
. Exposure to electrical office equipment.
. Personal protective equipment required such as protective eyewear, garments and gloves.
Why Join Us
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.