Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob Description• 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 PPD’s 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 SSU 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).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
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