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Senior Plain Language Summary Writer/Lay Summary Writer (Remote)

MMS Holdings Inc. Toledo, OH

  • Posted: over a month ago
  • Full-Time
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 www.mmsholdings.com or follow MMS on LinkedIn.

This role has an internal title of Senior 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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MMS Holdings Inc.

Address

Toledo, OH
43604 USA

Industry

Education

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