Country Approval Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

PPD, now Thermo Fisher’s clinical research business, 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 (https://www.ppdi.com/careers/about/culture) culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our dedicated 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.

Key responsibilities:

Prepares, reviews and coordinates,underguidance,localregulatory submissions (MoH, EC, additionalspecialnationallocal applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy

Provides, under guidance localregulatory strategy advice (MoH &/or EC) to internal clients

Provides project specificlocal 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 Regulatorysubmission-related activities

Coordinates,underguidance, with internalfunctional 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 forsiteactivation

Achieves PPD’s target cycle times for site

May work with the start-up CRA(s) to prepare the regulatorycompliance review packages

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, asrequired, 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 currentregulatory 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.

Education and Experience:

Bachelors degree orequivalent and relevantformalacademic / vocational qualification

Previous experience that provides the knowledge,skills,andabilities to perform the job (comparable to 2 years)

Background in regulatory activities, submissions and other responsibilities as part of the start-up CRO activities would be considered an advantage

Knowledge, Skills, and Abilities :

Effective verbal and written communication skills

Excellent interpersonalskills

Strongattentiontodetail and quality of documentation

Good negotiation skills

Good computerskills and the abilitytolearnappropriate software

Proficiencyin Georgianlanguageandgrammarskills

Fluent Englishlanguageandgrammarskills

Basic medical/therapeutic area and medical terminology knowledge

Ability to work in a teamenvironment or independently

Basic knowledge of all applicableregional / national country regulatory guidelines and EC regulations

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! ​

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.