About this role

Job Description

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.

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.
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Country Approval Associate (CAA)