Country Approval Specialist Germany

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.
• Key contact at country level for either Ethical or Regulatory submission-related 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 PPD\’s 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 understands 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 choose 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 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

Key Skills:

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