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Associate Medical Writer

2+ years
Not Disclosed
12 May 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Writer

Company Description:

PSI is a leading Contract Research Organization with over 28 years of industry experience, providing stability and innovation in delivering quality services across various therapeutic indications.

Job Description:

Responsibilities:

  1. Write, edit, and review Essential Documents, such as informed consent forms and patient information, ensuring accuracy and compliance.
  2. Develop, review, and finalize patient safety narratives for clinical study reports (CSRs) and track their progress.
  3. Collect and manage documents for CSR appendices, supporting Quality Control Associates and Associate Director, Medical Writing.
  4. Critically assess, interpret, and summarize data from clinical studies for inclusion in documents.
  5. Review relevant scientific literature to support medical writing activities.
  6. Perform quality control (QC) reviews of Essential Documents and other documentation developed by PSI.
  7. Act as a backup contact for Project Managers and other functional areas within assigned medical writing tasks.
  8. Collaborate with the Process Improvement team to develop patient safety narratives efficiently.

Qualifications:

  • Bachelor’s/Master’s degree in biomedical or life sciences fields, or relevant combination of education and experience.
  • Minimum 2 years of industry experience in working with clinical documentation and data.
  • Previous experience in pharmaceuticals, biotechnology, or contract research organizations.
  • Basic knowledge of global regulations and guidelines (FDA, ICH) pertaining to drug development and Essential Document production.
  • Familiarity with electronic Common Technical Document (eCTD) requirements.

Additional Information:

If you seek to showcase your skills and grow within a company that prioritizes its people, PSI offers a rewarding opportunity for career advancement.