Associate Medical Writer


Associate Medical Writer

  • Remote
  • United States
  • Employees can work remotely
  • Full-time

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,200 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

This position is for a department that works entirely remotely, reporting into multiple office locations in the US. The role itself is a fully home-based position.

  • Write, edit, and review Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
  • Perform quality control (QC) reviews of PSI-developed Essential Documents, such as clinical study protocols and clinical study reports (CSRs)
  • Write, edit, review, finalize, and track CSR safety narratives
  • Collect and track documents for CSR appendices
  • Critically assess, interpret, and summarize data from clinical studies
  • Review statistical analysis plans (SAPs) and scientific literature pertinent to medical writing activities

Qualifications

  • A minimum of 2 years of corresponding industry experience working with clinical documentation and data
  • Relevant educational background, such as a Bachelor’s or a Master’s degree in biomedical or life sciences fields, or an equivalent combination of education, training, and experience that presents the required knowledge, skills, and abilities.
  • Prior pharmaceutical, biotechnology, or contract research organization experience
  • Basic knowledge of global regulations and guidelines (FDA, ICH) on drug the development process and on production and publishing of Essential Documents
  • Basic knowledge of electronic Common Technical Document (eCTD) requirements
  • Intermediate proficiency in MS Office
  • Basic proficiency in Adobe Acrobat and Toolbox


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PSI CRO

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