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PPD

Senior Country Approval Specialist (Submissions) Site Start Up - Madrid

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times. Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.

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.

Responsibilities:


Job Qualification:

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 2+ 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


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 non-traditional 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 and


Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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