Country Approval Specialist – German Speaking

Stellenbeschreibung:

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.