Country Approval Specialist

Job Description

PPD, part of Thermo Fisher Scientific, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health We are vital links between an idea for a new medicine and the people who need it.

We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

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.

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, part of Thermo Fisher Scientific. 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.

What we offer:

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

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.