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Plain Language Summary Writer/Lay Summary Writer (Remote)

Company: MMS
Location: Detroit
Posted on: January 15, 2022

Job Description:

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

This role has an internal title of Transparency Specialist will provide operational support of:
Clinical Trial Disclosure
Clinical Trial Data Sharing,
Patient Lay Summaries/ Plain Language Summaries and,
Redaction of clinical trial documents in accordance with evolving global regulations.

Responsibilities
Perform clinical trial registration activities
Perform document redaction to remove confidential and personal information
Author lay summaries
Review documents and content as part of a quality check process
Manage timelines and communication with internal teams and/or stakeholders to ensure compliance
Track status of all active clinical trials and record clinical trial disclosure activities and compliance
Support administrative aspects of maintaining clinical trial registry and results summary posting

Requirements
Bachelor's Degree in a scientific, medical, or clinical discipline or related field is required; Master's or PhD preferred, or many years of related 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
Experience with Clinicaltrials.gov and/or EudraCT required
Has a strong attention to detail

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Keywords: MMS, Detroit , Plain Language Summary Writer/Lay Summary Writer (Remote), Advertising , Detroit, Michigan

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