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Senior Medical Writer – Regulatory Writing

Jordan Griffiths

Apply before: May 8, 2024
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  • Date posted
    March 9, 2024
  • Location
    Hybrid
  • Apply before
    May 8, 2024
  • Career Level
    Senior

Job Description

Description

Jordan Griffiths is seeking a talented and experienced Senior Medical Writer with expertise in regulatory writing to join his growing Biotech client. As a Senior Medical Writer, you will be responsible for producing high-quality documents that support the development and registration of pharmaceutical products.

Key responsibilities include:

  • Writing and editing clinical study protocols, investigator’s brochures, clinical study reports, and other regulatory documents
  • Reviewing and interpreting clinical trial data to ensure accurate and compelling presentation
  • Collaborating with cross-functional teams including regulatory affairs, clinical operations, and biostatistics
  • Ensuring compliance with relevant regulations and guidelines
  • Contributing to the development of templates and standard operating procedures

Requirements

Requirements:

  • Bachelor’s degree in life sciences or related field
  • Minimum of 3 years experience in regulatory medical writing
  • Strong knowledge of regulatory guidelines (ICH, FDA, EMA)
  • Excellent writing and editing skills with attention to detail
  • Proficiency in using relevant software and tools (MS Office, Adobe Acrobat)
  • Ability to work independently and collaboratively in a fast-paced environment
  • Strong organizational and time management skills

If you are a skilled medical writer with a focus on regulatory writing and seeking a challenging opportunity, we encourage you to apply.

Benefits

  • L&D funding for Conferences, networking and workshops
  • Annual Performance-Based Bonus
  • WFH and Remote working flexibility
  • Access to online training services
  • Stock Options