Country Approval Spec

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Summary
As a Country Approval Specialist, you will be part of our PPD clinical research team, where you’ll have the opportunity to support groundbreaking studies that make a real difference in patients’ lives. You will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy, which includes:

• Preparing, reviewing and coordinating, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
•Providing, under guidance, local regulatory strategy advice (MoH &/or EC) to internal clients.
•Providing project specific local SIA services and coordination of these projects.
•May have contact with investigators for submission related activities.
•Key contact at country level for either Ethical or Regulatory submission-related activities.
•Coordinating, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensuring alignment of submission process for sites and study are aligned to the critical path for site activation.
•Achieving PPD’s target cycle times for site.
•May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
•May develop country specific Patient Information Sheet/Informed Consent form documents.
•May assist with grant budgets(s) and payment schedules negotiations with sites.
•Supporting the coordination of feasibility activities, in accordance with agreed timelines.
•Entering and maintaining trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
•Ensuring the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
•Maintaining knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Required Education and Experience:

• 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 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 and Abilities:

• Effective oral and written communication 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,
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations