Country Regulatory Compliance Specialist
4 tygodni temu
Role Overview:
As a Country Approval Specialist, you will play a crucial role in the management and preparation of Country Submissions in line with global submission strategy to activate investigative sites.
Key Responsibilities:
- Coordinates and prepares local regulatory submissions (MoH, EC, special national local applications) in alignment with global submission strategy.
- Provides local regulatory strategy advice (MoH &/or EC) to internal clients.
- Coordinates project specific local SIA services and ensures alignment of submission process for sites and study with critical path for site activation.
- Ensures PPD's target cycle times for site activation.
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 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 the ability to learn appropriate software.
- 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.
Why Work with Us:
We're a global organization with a local feel, and we're committed to enabling our customers to make the world healthier, cleaner, and safer. Our team values integrity, intensity, innovation, and involvement, and we're dedicated to accelerating research, solving complex scientific challenges, and supporting patients in need.
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