Associate Medical Writer at PSI CRO 121 views

Job Description

We’re over 1600 strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for Teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way.

You are dynamic. You are curious. You are more than your job. For you, excellence isn’t just a word; it’s the measure for all you do. You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might be the team member we’re looking for.

Responsibilities

  • Primary responsibility for collecting documents for Clinical Study Report (CSR) appendices
  • Primary responsibility for tracking patient safety narratives for CSRs through writing, review, and finalization
  • Supervised responsibility for writing, editing, and review of essential study documents, including protocols, clinical study reports, narratives, informed consent forms, patient information, and other project-specific clinical documentation
  • Supervised responsibility for ensuring quality and compliance of essential study documents with applicable QSDs, pertinent regulatory requirements, and client specifications
  • Critically assess, interpret, and summarize data from clinical studies (subject to review by senior Medical Writing staff)
  • Review scientific literature pertinent to medical writing activities
  • Supervised responsibility for quality control (QC) reviews of essential study documents and other documentation
  • Backup contact for the customer and/or the sponsor (if not the same entity), Project Managers other PSI functional areas within the scope of assigned medical writing tasks

Job Requirements

  1. Relevant educational background, such as Bachelor’s or 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.
  2. Equivalency is defined as a minimum of 2 years of experience in medical or/and scientific writing.
  3. A minimum of 2 years of corresponding industry experience working with clinical documentation and data
  4. Prior pharmaceutical, biotechnology, or contract research company experience
  5. Basic knowledge of global regulations and guidelines (FDA, ICH) on drug development process and on production and publishing of essential study documents

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