Country Approval Specialist- Belgrade
PPD clinical research service`s mission is to improve health . It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams .
Our clinical department defines, develops and delivers clinical programmes. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study, ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.
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. Essential Functions of the role also include:
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 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 Qualifications:
Our team is expanding, so if this role seems interesting for you, here are the requirements: Education and Experience:
1+ year experience with submissions is mandatory 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 clinical research services we hire the best, develop ourselves and each other, and recognize 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 clinical research services 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 clinical research services 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 organization but with a local feel.
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!