Country Approval Specialist, Ukraine (Attractive Joining Bonus)
PPD is a leading global contract research organization. At PPD we are
passionate, deliberate, and driven by our purpose - to improve health.
Site and Patient Access is a global department working to provide rapid site
activation and patient access to our clients. Our innovative approach is designed to help
save our clients time and money while driving industry-leading cycle times. Working in
Site and Patient Access, you are a very important step in our commitment to industry leadership
and the relentless pursuit of excellence.
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.
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, 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
• Supports the coordination of feasibility activities, as required, in
accordance with agreed timelines
• Entes 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)
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
•
Basic organizational and planning skills
•
Basic knowledge of all applicable regional / national country regulatory guidelines and EC
regulations
At PPD we hire the best, develop ourselves and each other, and recognise the power of being
one team. We understand that you will want to grow both professionally and personally throughout
your career, and therefore at PPD you will benefit from an award-winning learning and development
programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based
around the health and well-being of our employees. We have a flexible working culture, where PPD
truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a
collaborative environment, with teams of colleagues eager to share expertise and have fun
together. We are a global organisation but with a local feel.
-
We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the
right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the
delivery of safe and effective therapeutics for some of the world’s most urgent health needs,
then please submit your application – we’d love to hear from you.
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