Senior Transparency Specialist (Remote)
- Posted: over a month ago
- Full-Time
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
The Senior Transparency Specialist will provide operational support of:
- Clinical Trial Transparency and Disclosure
- Clinical Trial Data Sharing
- Redaction and anonymization of clinical trial documents in accordance with evolving global regulations
Responsibilities:
- Responsible for providing high-quality transparency deliverables in an efficient manner
- Performs quality control reviews of document redaction or anonymization to ensure consistency and accuracy
- Maintain a strong understanding of regulations and guidance’s as they pertain to transparency; ensure deliverable timelines are compliant with regulatory timelines
- Lead projects with minimal management oversight, including complex projects with multiple team members; coordination independently with the client
- Tailors’ communication to diverse audience considering experience, background, and expectations
- Anticipate and understand customer’s needs and preferences and can provide solutions to customer’s needs; Develops deliverables according to customer specifications
- Effectively manage/ prioritize multiple deliverables and delegate as needed or implement workable solutions to complete deliverables on time
- Capable of leading Transparency process/tools improvements initiatives and may participate in complex companywide process improvement initiatives
- Facilitates and fosters positive team environment while supporting independent action to achieve team goals
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
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