Sr Country Approval Specialist

**Senior Country Approval Specialist (Start Up Specialist) - France**:
PPD clinical research services’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 clinical research services 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:

- 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 clinical research services WPD’s or client SOP’s

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 mínimal supervision, as required

At PPD clinical research services 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 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 organisation but with a local feel.

**Our 4i Values**:
Integrity - Innovation - Intensity - Involvement

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