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Senior Medical Writer, Clinical Research Documents

4 weeks ago


Bengaluru, Karnataka, India Parexel Full time
Job Summary

The Principal Medical Writer will be responsible for researching, creating, and editing all documents associated with clinical research. This includes protocols, clinical study reports, investigator's brochures, informed consent forms, and summary documents. The ideal candidate will have 10+ years of experience in regulatory medical writing and be proficient in multiple therapeutic areas. Strong communication and interpersonal skills are essential for this role, as well as the ability to work independently and lead projects. A bachelor's or advanced degree in life sciences or healthcare is required, and experience from the pharmaceutical/CRO industry is preferred.

Key Responsibilities
  • Research and create high-quality documents associated with clinical research
  • Develop and maintain strong relationships with clients and project teams
  • Collaborate with cross-functional teams to ensure timely and accurate document delivery
  • Stay up-to-date with industry trends and regulatory requirements
  • Provide technical mentoring and training to junior writers
Requirements
  • 10+ years of experience in regulatory medical writing
  • Proficient in multiple therapeutic areas
  • Strong communication and interpersonal skills
  • Ability to work independently and lead projects
  • Bachelor's or advanced degree in life sciences or healthcare
  • Experience from the pharmaceutical/CRO industry preferred