Location: Europe, Middle East & Africa-Germany
Closing Date: 25 Oct 16
Type: Full Time
Salary (£): On Application
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. ...
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
- 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
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