Senior Medical Content Specialist

1 month ago


Bengaluru, Karnataka, India VCLS Full time
Senior Medical Writer/Medical Writer

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

Key Responsibilities:

  • Act as the lead medical writer on client programs, ensuring the highest quality of deliverables.
  • Review draft and final documents prepared by VCLS consultants or clients, ensuring accuracy, consistency, and adherence to regulatory standards.
  • Draft and/or review clinical and regulatory documents, including study protocols, investigator brochures, clinical study reports, and clinical overviews.
  • Contribute to the writing of other regulatory documents, such as Orphan Drug Designation applications and Pediatric Investigation Plans.
  • Ensure that 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.
  • Participate in client meetings and support business development activities as needed.

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, including study protocols, investigator brochures, and clinical study reports.
  • 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.
  • Knowledge of reference management and publication planning tools is a plus.


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