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.
We are now establishing a new clinical operations team in Estonia and are looking for colleagues passionate about clinical trials and start-up.

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 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, CTR and local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, non-interventional applications) in alignment with global submission strategyProvides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clientsProvides project specific local start-up services and coordination of these projectsMay have contact with investigators for submission related activitiesKey-contact at country level for start-up activitiesCoordinates, 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 activationAchieves PPD’s target cycle times for siteMay work with the start-up CRA(s) to prepare the regulatory compliance review packagesMay develop country specific Patient Information Sheet/Informed Consent form documentsEnters and maintains trial status information relating to start-up activities onto PPD tracking databases in an accurate and timely mannerEnsures the local country study files and filing processes are prepared, set up and maintained as per SOPsMaintains knowledge of current regulatory guidelines as applicable to services provided

Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities 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 skillsExcellent interpersonal skillsStrong attention to detail and quality of documentationGood negotiation skillsGood computer skills and the ability to learn appropriate softwareProficiency in Estonian and English language and grammar skillsBasic medical/therapeutic area and medical terminology knowledgeAbility to work in a team environment or independentlyBasic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com