Country Approval Specialist

at  Thermo Fisher Scientific

JOB DESCRIPTION

PPD, now Thermo Fisher’s 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 life-saving 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 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
• Achieves PPD’s target cycle times for site
• May work with the start-up 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:

• Bachelor’s 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 start-up 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 Georgian language and grammar skills
• Fluent 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

Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you

• 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 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
• Achieves PPD’s target cycle times for site
• May work with the start-up 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 provide