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Country Approval Specialist (AMER)

Company: Aerotek
Location: Remote
Posted on: April 9, 2021

Job Description:

Description:Participates in the management and preparation, review and coordination of Country Submissions in line with global submission strategy.

  • 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 PPDs 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.
  • 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 current regulatory guidelines as applicable to services provided.Additional Skills & Qualifications:Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years) or equivalent combExperience Level:Entry Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Eugene , Country Approval Specialist (AMER), Other , Remote, Oregon

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