Associate Medical Writer

Hiring By - Biostaffic


Job Highlights

Not Disclosed

Remote Job


Posted 4 months ago
Job details
Company Description
PSI is a leading Contract Research Organization with more than 28 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
  • Writes, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
  • Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
  • Collects and tracks documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing
  • Critically assesses, interprets, and summarizes data from clinical studies
  • Reviews scientific literature pertinent to medical writing activities
  • Performs quality control (QC) reviews of PSI-developed Essential Documents and other documentation (in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing)
  • Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
  • Collaborates with the Process Improvement narrative automation team to develop patient safety narratives
  • College or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life sciences fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities.
  • Minimum 2 years of corresponding industry experience working with clinical documentation and data
  • Prior pharmaceutical, biotechnology, or contract research organization experience
  • Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
  • Basic knowledge of electronic Common Technical Document (eCTD) requirements
Additional Information
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • Associate

Remote Job:

  • Yes

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview

Current Openings: 0

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
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