Global Transparency Expert

2 days ago


Canton, Michigan, United States MMS Full time
Job Overview

MMS is an award-winning, data-focused clinical research organization (CRO) with a global footprint across four continents. We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate.

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With an industry-leading customer satisfaction rating, MMS fosters a collaborative and inclusive work environment where employees can thrive.

About the Role

The Senior Transparency Specialist will play a key role in providing operational support for Clinical Trial Transparency, Clinical Trial Data Sharing, and Redaction and Anonymization of clinical trial documents in accordance with evolving global regulations.

  • Responsible for delivering high-quality transparency deliverables efficiently.
  • Tech expertise on regulatory requirements (EMA Policy 0070, HC PRCI, EU-CTIS etc.).
  • Facilitates the exchange of information for all Transparency workflow steps.
  • Performs quality control reviews to ensure consistency and accuracy.

This role requires a strong understanding of regulations and guidance's as they pertain to transparency, ensuring deliverable timelines are compliant with regulatory timelines.

Key Responsibilities
  • Lead projects with minimal management oversight, including complex projects with multiple team members.
  • Coordinate independently with clients.
  • Tailor communication to diverse audiences.
  • Anticipate and understand customer needs and preferences.
  • Develop deliverables according to customer specifications.
  • Effectively manage/prioritize multiple deliverables and delegate as needed.
  • Facilitate and foster positive team environments.
Requirements
  • Bachelor's Degree in a scientific, medical, or clinical discipline or related field preferred; or 5 years of experience if less than a Bachelor's.
  • At least 3 years of previous transparency experience.
  • Hands-on experience with clinical trials and pharmaceutical development preferred.
  • Effective problem-solving and data analysis skills.
  • Experience in the pharmaceutical or CRO industry highly preferred.
Salary Range

$85,000 - $110,000 per year, depending on experience and qualifications.



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