Transparency Operations Expert
5 days ago
We are seeking a highly skilled Senior Transparency Specialist to provide operational support for clinical trial transparency, data sharing, and regulatory compliance.
About MMSMMS 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. Our team is dedicated to fostering a collaborative and inclusive work environment where employees can thrive.
As a Senior Transparency Specialist at MMS, you will play a crucial role in providing high-quality transparency deliverables in an efficient manner. You will be responsible for technical expertise on regulatory requirements, facilitating the exchange of information for all transparency workflow steps, and performing quality control reviews of document redaction or anonymization.
Key Responsibilities:
- Provide high-quality transparency deliverables in an efficient manner.
- Technical expertise on regulatory requirements (EMA Policy 0070, HC PRCI, EU-CTIS, etc.).
- Facilitate the initiation, progression, and completion of the exchange of information for all transparency workflow steps.
- Perform quality control reviews of document redaction or anonymization to ensure consistency and accuracy.
- Maintain a strong understanding of regulations and guidance as they pertain to transparency; ensure deliverable timelines are compliant with regulatory timelines.
Requirements:
- Bachelor's Degree in a scientific, medical, or clinical discipline or related field is 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.
- Has a strong attention to detail.
Estimated Salary Range: $85,000 - $110,000 per year
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