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Country Approval Specialist (Submissions Specialist) - UK/IRE

Employer
PPD
Location
Cambridge, United Kingdom
Salary
Competitive
Start date
1 Aug 2022
Closing date
31 Aug 2022

View more

Discipline
Clinical Research, Study Start Up
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Country Approval Specialist (Submissions) - UK/IRE

£7,500 SIGN ON BONUS CURRENTLY BEING OFFERED FOR EXPERIENCE SUBMISSIONS SPECIALISTS TO JOIN PPD!

PPD’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 goal-driven 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.

We are currently looking for an experienced Country Approval Specialist to join our team in the UK. As a Country Approval Specialist, you will be responsible for:

  • Preparing, reviewing and coordinating local regulatory submissions (MoH, EC, additional special national local applications if applicable)
  • Providing local regulatory strategy advice (MoH &/or EC) to internal clients
  • Developing and implementing local submission strategy
  • Providing technical expertise and coordination oversight for projects
  • Acting as the primary contact for investigators and with the local regulatory authorities to ensure submissions are managed in a timely manner
  • Acting as a key-contact at country level for all submission-related activities
  • Achieving PPD’s target cycle times for site activations
  • Preparing the regulatory compliance review packages
  • Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy
  • Developing country specific Patient Information Sheet/Informed Consent form documents
  • Supporting the coordination of feasibility activities, as required, in accordance with agreed timelines.
  • Ensuring that trial status information relating to SIA activities are accurately maintained
  • Overseeing country study files and ensures that that they meet PPD WPD’s or client SOP’s


Qualifications:

To be considered for the role of Country Approval Specialist you should have:
  • Bachelor's degree in Life Science related discipline
  • Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations
  • Effective oral and written communication skills, including fluency in English
  • Strong attention to detail and quality of documentation
  • Excellent negotiation and interpersonal skills

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.

#LI-KB2

Company

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

 

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Find Us
Website
Location
Granta Park
Great Abington
Cambridge
CB21 6GQ
United Kingdom
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