Regulatory Compliance Specialist for Clinical Research

Há 1 mês


Lisboa, Lisboa, Portugal Ppd Latin America Tempo inteiro
Job Summary

We are seeking an experienced Regulatory Compliance Specialist for Clinical Research to join our team at Ppd Latin America. As a key member of our operations, you will be responsible for ensuring the efficient delivery of contracts and managing local regulatory submissions in accordance with global submission strategy.

About the Role
  • Prepare, review, and coordinate local regulatory submissions (MoH, EC, special national local applications) under guidance;
  • Draft, review, negotiate, and finalize agreements with study sites according to local/accepted process;
  • Negotiate within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company, client, and established process;
  • Evaluate legal, financial, and operational risks and escalate to appropriate level per established processes;
  • Provide recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels;
  • Coordinate with internal functional departments to ensure site startup activities align with contractual activities and mutually agreed timelines;
About You

To succeed in this role, you will need:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification;
  • Previous experience providing knowledge, skills, and abilities comparable to 2-5 years;
  • Good understanding of contract law principles and laws influencing contract language;
  • Demonstrated ability to apply basic principles of investigator grant negotiation;
  • Effective communication skills (verbal & written) in English and local language;
  • Able to work independently or in a team environment with good organizational and time management skills.
What We Offer

As a valued member of our team, you can expect:

  • A competitive salary range of $80,000 - $120,000 per year, depending on experience;
  • An extensive benefits package focused on employee health and well-being;
  • A flexible working culture that prioritizes work-life balance;
  • Opportunities for professional growth and development through our award-winning learning program.


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