Job - Freelance / Consultant Regulatory Medical Writer

Job Description

Organization: Crixus Health

Engagement: Project-based (Remote / Flexible)

Experience: More than 5 years of relevant experience in any of the regulatory documents mentioned below

About the Role

Crixus Health is building a dynamic team of Regulatory Medical Writers (Freelance/Consultants) to support clinical and regulatory documentation across diverse therapeutic areas. We are seeking experienced consultants and freelancers who can collaborate on a project basis to deliver high-quality, compliant, and scientifically accurate documents.

Key Responsibilities

• Develop and author regulatory documents including:

  
  

  • Clinical Study Protocols (CSP)

  • Common Technical Documents (CTD)

  • Investigator’s Brochure (IB)

  • Risk Management Plans (RMP)

  • Informed Consent Forms (ICF)

  • Patient Narratives

  • Clinical Study Reports (CSR)

    
    

• Ensure documents adhere to ICH-GCP guidelines, regulatory requirements, and sponsor specifications.

• Collaborate with cross-functional teams (clinical, regulatory, biostatistics, pharmacovigilance).

• Interpret clinical data and present it clearly, concisely, and accurately.

• Maintain consistency in style, terminology, and formatting across documents.

• Deliver projects within agreed timelines while maintaining high quality standards.

  
  

Qualifications & Skills

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field.

• Minimum 5 years of experience in regulatory medical writing.

• Strong knowledge of clinical trial processes, ICH guidelines, and regulatory frameworks.

• Excellent written and verbal communication skills.

• Ability to work independently and manage multiple projects simultaneously.

• Familiarity with document management systems and templates.

  
  

Why Join Us?

• Flexible, project-based assignments.

• Opportunity to collaborate with a growing healthcare communications company.

• Exposure to diverse therapeutic areas and global regulatory standards.

• Work remotely with a supportive and professional team.

  
  

Application Process

Interested consultants and freelancers may share their details in the google form.

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