PPD now has an exciting new opportunity in Germany for a Country Approval Specialist to join our Site Intelligence & Activation team.
This is an office based, full-time position, located in either Munich or Karlsruhe, Germany.
In this role you will:
- Prepare, review and coordinate, local regulatory submissions (MoH, EC, additional special national local applications if applicable. in alignment with global submission strategy - Provide local regulatory strategy advice (MoH &/or EC) to internal clients - Provide project specific local SIA services and coordination of these projects - May have contact with investigators for submission related activities - Key-contact at country level for Ethical and Regulatory submission-related activities - Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation - Prepare the regulatory compliance review packages, as applicable - Develop country specific Patient Information Sheet/Informed Consent form documents - May assist with grant budgets(s) and payment schedules negotiations with sites. - Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner - Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs - Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
QualificationsBachelor's degree - 2 years related experience preferred, or equivalent combination of education, training, & experience
Required Knowledge, Skills and Abilities:
- 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 - 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