Country Approval Specialist Germany
Country Approval Specialist Germany
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
PPD now Thermo Fishers clinical research business is a leading global contract research organization providing comprehensive integrated drug development laboratory and lifecycle management services.
At PPD we are passionate deliberate and driven by our purpose to improve health!
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving therapies to patients.
Our dedicated teams combine and deliver startup activities for the clinical trials collaborating to improve processes cycle and flexibility. We partner with our sites businesses and colleagues around the world to decrease startup timelines and exceed expectations.
As a Country Approval Specialist you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail taking ownership of the accuracy of these documents while holding yourself and others accountable.
Key responsibilities:
- Prepares reviews and coordinates under guidance local regulatory submissions (MoH EC additional special national local applications if applicable e.g. gene therapy approvals viral safety dossiers import license) in alignment with global submission strategy
- Provides under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
- Provides project specific local SIA services and coordination of these projects
- May have contact with investigators for submission related activities
- Keycontact at country level for either Ethical or Regulatory submissionrelated activities
- Coordinates under guidance with internal functional departments to ensure various site startup 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
- Achieves PPDs target cycle times for site
- May work with the startup CRA(s) to prepare the regulatory compliance review packages
- May develop country specific Patient Information Sheet/Informed Consent form documents
- May assist with grant budgets(s) and payment schedules negotiations with sites
- Supports the coordination of feasibility activities as required in accordance with agreed timelines
- Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
- Ensures the local country study files and filing processes are prepared set up and maintained as per PPD WPDs or applicable client SOPs
- Maintains knowledge of and understand PPD SOPs Client SOPs/directives and current regulatory guidelines as applicable to services provided
Grow your career as a Senior Country Approval Specialist a Feasibility Specialist or a Site Contract Specialist all supporting site activation. You could move into the country management career track managing a country or groups of countries for site activation. Or pursue other paths within our Global Clinical Development group. These are just a few career pathways available once you chose to be with PPD.
Education and Experience:
- Bachelors degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years)
- Background in regulatory activities submissions and other responsibilities as part of the startup CRO activities would be considered an advantage
Knowledge Skills and Abilities:
- Effective verbal 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
- Proficiency in German and English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
Required Experience:
Unclear Seniority
Employment Type
Full-Time
