Country Approval Specialist
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Job Description
Country Approval Specialist coordinating Malaysian clinical-trial regulatory submissions for PPD. Managing country approvals, site start-up activities, and regulatory documentation.
Responsibilities:
- Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy
- Provide local regulatory strategy advice to internal clients under guidance
- Provide and coordinate project-specific local SIA services
- Contact investigators for submission-related activities as needed
- Serve as country-level key contact for ethical or regulatory submission activities
- Coordinate with internal functional departments on site start-up activities and submission timelines
- Ensure submission processes align with critical paths for site activation
- Achieve target cycle times for sites
- Work with start-up CRAs on regulatory compliance review packages as applicable
- Develop country-specific Patient Information Sheets/Informed Consent forms as needed
- Assist with grant budgets and payment schedule negotiations with sites
- Support feasibility activities according to agreed timelines
- Enter and maintain trial status information in PPD tracking databases
- Prepare, set up and maintain local country study files and filing processes
- Maintain knowledge of PPD SOPs, client SOPs/directives and current regulatory guidelines
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 2+ years
- 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/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 applicable regional/national country regulatory guidelines and EC regulations
- Equivalency may consist of appropriate education, training and/or directly related experience
- Ability to work in office/laboratory and/or clinical environments
- Ability to use required personal protective equipment
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