Country Approval Specialist

hace 3 semanas

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

Description - External

  • We are vital links between an idea for a new medicine and the people who need it.
We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose:
to improve health.

You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.


  • Our goaldriven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.
  • As a Country Approval Specialist, you will be responsible for pulling regulatory Country Submissions together in order to activate investigative sites.
  • At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
  • Summarized Purpose:
  • As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.
  • Essential Functions:
  • 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
  • Keycontact at country level for either Ethical or Regulatory submissionrelated activities
  • Coordinates, under guidance, with internal functional departments to ensure various site startup 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 startup 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 provide

Qualifications - External

  • 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 2+ years)
  • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • 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

Working Environment:

  • PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment/requirements for this role:

  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
  • Able to work upright and stationary and/or standing for typical working hours
  • Able to lift and move objects up to 25 pounds
  • Able to work in nontraditional work environments
  • Able to use and learn standard office equipment and technology with proficiency
  • May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments
  • Able to perform successfully under pressure while prioritizing
  • PPD Defining Principles:
  • We have a strong will to win
  • We earn our customer's trust
  • We are gamechangers
  • We do the right thing We are one PPD

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