Country Approval Specialist – German Speaking

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Prepare, assess, and coordinate local regulatory submissions in alignment with the global submission strategy.

• Offer local regulatory strategy guidance to internal clients under supervision.

• Provide and oversee project-specific local SIA services.

• Reach out to investigators for submission-related tasks as necessary.

• Act as the primary country-level contact for ethical or regulatory submission activities.

• Collaborate with internal functional departments regarding site start-up activities and submission timelines.

• Ensure that submission processes are consistent with the critical path for site activation.

• Meet PPD's target cycle times for sites.

• Work alongside start-up CRAs to prepare regulatory compliance review packages when applicable.

• Create country-specific Patient Information Sheets/Informed Consent forms as required.

• Aid in grant budget and payment schedule negotiations with sites.

• Support feasibility activities in accordance with agreed timelines.

• Enter and maintain trial status information in PPD tracking databases.

• Prepare, establish, and manage local country study files and filing processes.

• Keep up to date with PPD and client SOPs/directives, as well as relevant regulatory guidelines.

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant formal academic/vocational qualification.

• Over 2 years of prior experience providing the knowledge, skills, and abilities needed to perform the role.

• Equivalency may include a combination of suitable education, training, and/or directly related experience.

• Proficient in English and German at an advanced level.

• Exceptional interpersonal skills.

• Strong attention to detail and quality in documentation.

• Effective negotiation skills.

• Competent computer skills and the ability to learn relevant software.

• Good command of the English language and grammar.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Capability to work in a team environment or independently, as needed, under guidance.

• Basic organizational and planning abilities.

• Fundamental knowledge of applicable regional/national country regulatory guidelines and EC regulations.

• Ability to function in office/laboratory and/or clinical settings.

• Proficiency in using necessary personal protective equipment, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.