Sr. Medical Writer Clinpharm (csr, Ib, Protocol)

Syneos Health

Remote
Medical writing of clinical documents
Knowledge of fda and ich regulations
Experience with biopharmaceutical industry
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 leading and managing medical writing deliverables such as clinical study reports, protocols, investigator brochures, and regulatory submissions while ensuring adherence to regulatory standards and quality.
  • Syneos Health fosters a Total Self culture that supports career development, diversity, and inclusion, and offers opportunities to work in a collaborative and innovative environment.

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

  • Medical writing of clinical documents
  • Knowledge of FDA and ICH regulations
  • Experience with biopharmaceutical industry
  • Strong English grammar and AMA style
  • Coordination of medical writing activities
  • Peer reviewing and mentoring skills

Nice-to-have

  • Ability to simplify and streamline work
  • Collaborative team environment
  • Passion for accelerating therapy delivery
  • Commitment to diversity and inclusion
  • Technical and therapeutic area training
  • Providing training and consultation

Key Requirements

  • 3-5 years relevant medical writing experience
  • Experience in biopharmaceutical or CRO industry
  • Strong understanding of FDA and ICH guidelines
  • Experience writing clinical study documents
  • Familiarity with AMA Manual of Style
  • Ability to work remotely
  • Minimal travel (less than 25%)

Work Rights

Not specified

Tailored Resume

Cover Letter