Thermo Fisher Scientific

sites and study are aligned to the critical path for site activation.. May work with the start-up CRA(s) to prepare the regulatory compliance review. Entes and maintains trial status information relating to SIA activities onto PPD. and maintained as per PPD WPDs or applicable client SOPs.. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and

Ctry Approval Spec

Job DescriptionAs PPD CAA/CAS, the following will be the responsibilities: Prepares, reviews and coordinates, under guidance, local regulatory submissions(MoH, EC, additional special national local applications if applicable, e.g. genetherapy approvals, viral safety dossiers, import license) in alignment with globalsubmission strategy. Provides, under guidance local regulatory strategy advice (MoH &/or EC) tointernal clients. Provides project specific local SSU 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-relatedactivities. Coordinates, under guidance, with internal functional departments to ensurevarious site start-up activities are aligned with submissions activities andmutually agreed upon timelines; ensures alignment of submission process forsites and study are aligned to the critical path for site activation. Achieves PPDs target cycle times for site. May work with the start-up CRA(s) to prepare the regulatory compliance reviewpackages, as applicable. May develop country specific Patient Information Sheet/Informed Consent formdocuments. May assist with grant budgets(s) and payment schedules negotiations with sites. Supports the coordination of feasibility activities, as required, in accordance withagreed timelines. Entes and maintains trial status information relating to SIA activities onto PPDtracking databases in an accurate and timely manner. Ensures the local country study files and filing processes are prepared, set upand maintained as per PPD WPDs or applicable client SOPs. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, andcurrent regulatory guidelines as applicable to services provided.Qualifications: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 to2+ years)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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