Ctry Approval Specialist

Work Schedule
Other

Environmental Conditions
Office

Job Description

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. 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

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.

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