Country Approval Specialist (AMER)
Posted on: April 9, 2021
Description:Participates in the management and preparation,
review and coordination of Country Submissions in line with global
- Prepares, reviews and coordinates, under guidance, local
- (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
- Key-contact at country level for either Ethical or Regulatory
- 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
- Ensures the local country study files and filing processes are
prepared, set up and maintained as per PPD WPDs or applicable
- 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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