Clinical Documentation Specialist

3 weeks ago


London, Greater London, United Kingdom MMS Full time

About MMS

MMS is an innovative data-focused Contract Research Organization (CRO) supporting the pharmaceutical, biotech, and medical device industries with a proven scientific approach to complex trial data and regulatory submission challenges.

With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and has been recognized as a leading CRO in Global Health & Pharma's international awards programs for the last three consecutive years.

  • The Regulatory Writer will critically evaluate, analyze, and interpret medical literature to select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias.
  • They will write and edit clinical development documents, including clinical protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.5 documents, presentation materials, and publications to medical journals.
  • They must complete writing assignments on time and maintain project timelines.
  • The ideal candidate will practice excellent internal and external customer service and communicate effectively with clients.

Job Requirements

  • Bachelor's, Master's, or Ph.D. degree in a scientific, medical, or clinical discipline is required, along with at least 6 years of previous regulatory writing experience. A Master's or Ph.D. degree is preferred.
  • Substantial clinical study protocol experience as lead author is required.
  • The candidate should have experience managing teams while authoring regulatory documents with aggressive timelines.

Estimated Salary: $140,000 - $200,000 per year



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