- Prepare, review and coordinate local regulatory submissions in alignment with the 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 the critical path for site activation
- Achieve PPD target cycle times for sites
- Work with start-up CRAs to prepare regulatory compliance review packages as applicable
- Develop country-specific Patient Information Sheets/Informed Consent forms as needed
- Assist with grant budget 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 and client SOPs/directives and applicable regulatory guidelines
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job
- Equivalency may consist of a combination of appropriate education, training and/or directly related experience
- Advanced level of English and German
- 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
- Ability to work in office/laboratory and/or clinical environments
- Ability to use required personal protective equipment, including protective eyewear, garments and gloves
Core Competencies
Demonstrates expertise in local regulatory submissions and compliance, with strong capabilities in project coordination and negotiation. Proficient in maintaining documentation quality and adhering to regulatory guidelines in clinical environments.
Highest-signal resume keywords
- Regulatory Submissions
- Project Coordination
- Negotiation Skills
- Attention to Detail
- English And German Proficiency
ATS Optimization Keywords
Hard Skills
- Regulatory Compliance
- Patient Information Sheets Development
- Informed Consent Forms Preparation
- Trial Status Information Management
- Knowledge Of Medical Terminology
- SOPs And Directives Knowledge
- Submission Process Alignment
- Feasibility Activities Support
- Site Activation Processes
- Budget Negotiation
Soft Skills
- Interpersonal Skills
- Organizational Skills
- Planning Skills
- Teamwork
- Independent Work
Certifications & Qualifications
- Bachelor's Degree Or Equivalent
Industry Keywords
- Regulatory Guidelines
- Ethical Submission Activities
- Clinical Environments
- Country Regulatory Guidelines
- EC Regulations
Tools & Technologies
- PPD Tracking Databases
- Clinical Trial Management Software
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Country Approval Specialist – German Speaking Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
