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Country Approval Specialist Germany
- Permanent
- Clinical Scientist
- Germany
This vacancy has now expired. Please see similar roles below...
An opportunity has arisen for a Country Approval Specialist, in Germany. This is an exciting opportunity to join a startup delivering the set up for Clinical trials, collaborating to improve processes, cycle and flexibility.
Job Responsibilities
- Prepare, review and coordinate, under guidance, local regulatory submissions in alignment with global submission strategy
- Provide, under guidance local regulatory strategy advice 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 either Ethical or Regulatory submission-related activities
- May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
- May develop country specific Patient Information Sheet/Informed Consent form documents
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Support the coordination of feasibility activities, as required, in accordance with agreed timelines
- 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
Skills and Requirements
- Bachelor's degree
- 0 - 2 years related experience or equivalent combination of education, training, & experience
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Excellent English and German language and grammar skills at least to C1 level
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation
To Apply
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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