Senior Start Up Specialist - France

PPD

FR Ivry sur Seine Ced Ivry sur Seine Cedex FR PVC

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Job Description

Senior Country Approval Specialist (Start Up Specialist) - France 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.

PPD are currently hiring for an experienced Senior Country Approval Specialist to join our Site Intelligence & Activation team in France.

As a Senior 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

Job Qualification

To be considered for the role of Sr Country Approval Specialist you should have :

Bachelor's degree in Life Science related discipline

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)

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

Good negotiation and interpersonal skills

Good computer skills and the ability to learn appropriate software

Good judgment and decision-making skills

Basic medical / therapeutic area and medical terminology knowledge

Ability to work in a team environment or independently, with minimal supervision, as required

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.

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone. #LI-AD1

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