Clinical Regulatory Writer

Company Overview

Company details are currently unavailable.

Job Summary

The Clinical Regulatory Writer plays a crucial role in the pharmaceutical industry, responsible for the creation of high-quality clinical regulatory documents. This position requires expertise in analyzing and documenting clinical data while ensuring compliance with industry standards to support the development and approval of pharmaceuticals.

Responsibilities

• Prepare and manage clinical regulatory documents required for submissions to health authorities.
• Collaborate with cross-functional teams to interpret and document clinical data effectively.
• Demonstrate leadership in project management and provide guidance in multicultural settings.
• Ensure compliance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines.
• Utilize strong computer skills for document formatting and data analysis.
• Communicate complex information clearly in both verbal and written English.

Qualifications

• Education: PhD or relevant working experience within the life sciences space.
• Experience: Clinical regulatory writing in the pharmaceutical industry.
• Skills:
  • Leadership abilities.
  • Experience working in multicultural environments.
  • Proficient in interpreting and documenting clinical data.
  • Knowledge of ICH/GCP standards.
  • Strong computer skills and general computer literacy.
  • Excellent English language skills (verbal and written).

Preferred Skills

• Additional experience in remote teamwork and collaboration with diverse groups is advantageous. Familiarity with regulatory submission processes would be a plus.

Experience

• Minimum of relevant experience in clinical regulatory writing, particularly within the pharmaceutical sector.

Environment

Details on the typical work setting, location, or physical conditions are not provided.

Salary

Salary information is currently unavailable.

Growth Opportunities

Opportunities for career advancement within the pharmaceutical industry exist, although specific pathways are not detailed.

Benefits

Information regarding benefits offered for this position is not specified.