Instagram
youtube
Facebook

Medical Writer (Clinical Sop Writer) - Remote

0-5 years
Not Disclosed
10 May 21, 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 Summary: Clinical SOP Writer


Overview:

The Clinical SOP Writer is responsible for editing and performing quality control (QC) reviews of clinical procedures. This role involves working with Process Owners, Subject Matter Experts (SMEs), and relevant stakeholders to develop and revise clinical procedures. The Writer ensures that procedures, forms, and templates adhere to high-quality standards and the company's writing style guide, as well as standards for clinical procedures/documents.


Requirements:

  • Education:

    • Bachelor’s degree in English or a related subject, or
    • Bachelor’s degree in science with proven writing experience.
  • Experience:

    • Experience in the pharmaceutical industry with knowledge of clinical development.
    • Proven writing, editing, and quality control review experience.
    • Experience in applying writing style guidelines and standards.
    • Experience across multiple disciplines within clinical development in the pharmaceutical industry, with knowledge of the drug development process.
    • Proven experience in developing, maintaining, and using electronic templates.
    • Experience working in an electronic document management system.
  • Skills:

    • Proficiency in MS Word and Excel.
    • Strong working knowledge of clinical development functions and processes, compliance standards, and ICH, GCP, and regulatory requirements.
    • Customer-focused approach with strong project management, multitasking, and interpersonal skills.
    • Excellent communication skills, both oral and written, at all levels.

Responsibilities:

  • Edit and perform QC reviews of clinical procedures.
  • Work with Process Owners, SMEs, and stakeholders to develop and revise clinical procedures.
  • Ensure that procedures, forms, and templates are written to a high-quality standard.
  • Adhere to the company’s writing style guide and standards for clinical procedures/documents.