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Senior Medical Writer/Medical Writer

1 month ago

Bengaluru, Karnataka, India VCLS Full time
{"title": "Senior Medical Writer/Medical Writer", "description": "Key Responsibilities

VCLS is seeking a highly skilled Senior Medical Writer/Medical Writer to author high-quality medical documents for various client projects.

Key Responsibilities:

  • Lead medical writing on client programs, ensuring high-quality deliverables.
  • Review and finalize documents prepared by VCLS consultants or clients, ensuring accuracy and consistency.
  • Draft and/or review clinical and regulatory documents, including study protocols, investigator brochures, and clinical study reports.
  • Contribute to the writing of other regulatory documents, such as Orphan Drug Designation applications and Pediatric Investigation Plans.
  • Ensure all documents comply with VCLS or client SOPs and style requirements.
  • Provide input into project scope and cost estimates.
  • Stay updated on relevant regulations and guidelines in medical writing.
  • Collaborate closely with cross-functional teams, including scientists, researchers, and regulatory affairs professionals.
Requirements

Requirements:

  • Minimum of 5+ years of experience as a Medical Writer in the pharmaceutical or biotech industry.
  • Bachelor's degree or higher in a scientific discipline.
  • Regulatory expertise.
  • CRO experience is preferable.
  • Strong understanding of ICH guidelines and regulatory requirements.
  • Experience with authoring clinical and regulatory documents.
  • Excellent written and verbal communication skills.
  • Attention to detail and ability to prioritize tasks to meet deadlines.
  • Proficient in MS Office (Word, Excel, PowerPoint).
  • Ability to work independently and collaboratively within a team.
", "lang_code": "en"}