Medical Writer Ii (clinical Trial Transparency)

Syneos Health

Remote
Experience in clinical trial disclosure
Knowledge of clinical registries ct.gov and ctis
Proficiency in medical writing deliverables
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success by placing the customer and patient at the center of clinical development

Job Summary

  • Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success by placing the customer and patient at the center of clinical development.
  • The role involves compiling, writing, and editing a variety of clinical documents including study protocols, reports, patient narratives, and investigator brochures with adherence to regulatory standards.
  • The company fosters a Total Self culture promoting diversity, career development, and a supportive work environment where employees can authentically be themselves.

Matching Summary

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success by placing the customer and patient at the center of clinical development.

Skills & Requirements

Must-have

  • Experience in clinical trial disclosure
  • Knowledge of clinical registries CT.gov and CTIS
  • Proficiency in medical writing deliverables
  • Understanding of FDA and ICH regulations
  • Strong proficiency in MS Office
  • Experience with Pharma CM/Disclose databases

Nice-to-have

  • Strong presentation and proofreading skills
  • Collaborative and interpersonal skills
  • Strong project and time management skills
  • Mentoring less experienced writers
  • Familiarity with AMA Manual of Style
  • Client interaction experience

Key Requirements

  • 1 to 3 years of experience in disclosure
  • Bachelor's degree in relevant discipline
  • Graduate degree preferred
  • Strong understanding of FDA and ICH regulations
  • Experience writing relevant document types
  • Client interaction experience

Work Rights

Not specified

Tailored Resume

Cover Letter