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Posted May 05

Medical Writer 2- Home Based

PRA Health Sciences
United States of America Full Time

Overview:

  • Good understanding of drug development, clinical research, study design, biostatistics, and medical terminology
  • Experience preparing clinical regulatory documents and/or experience in summarizing scientific information
  • Knowledge of regulatory requirements for clinical trial disclosure
  • Working knowledge and familiarity with ClinicalTrials.gov and EudraCT
  • Detail-oriented with excellent inter-personal and communication skills.
  • Ability to work both independently and collaboratively with a team in a cross-cultural environment
  • Excellent written and spoken English

Responsibilities:

  • Under minimal supervision, prepares or oversees preparation of clinical trial information for posting on defined websites, whether study information or study results, as well as related tasks - quality control, corrections, communications with teams, filing, and archiving. Proactively manages project timelines. Provides and maintains data to allow visibility of progress, tracking of disclosure milestones, and supervision of workload. May support selected aspects of maintaining varied clinical trial registry and results information on websites. Activity can include ‘redacting’ documents for data-sharing purposes. In addition, quality activities to ensure the compliance and/or consistency of information may include application of quality checklists and sampling methods, as well as occasionally compiling, assessing and exploiting disclosure data from various cross-entity environments and websites. Familiarity with document management systems, databases, public and corporate websites is needed.

Qualifications:

Qualifications:

  • Life Sciences degree, at minimum a Bachelors
  • Project management training and experience
  • Exposure to large corporate environments and international teams
  • Mastery of WORD and Excel




  • Advanced degree (M.S., PharmD, Ph.D.) preferred





PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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