Medical Writer

3 days ago

Hyderabad, Telangana, India Lifelancer Full time ₹ 9,00,000 - ₹ 12,00,000 per year
Company DescriptionJob Description
  • QC and formatting of clinical trial protocols, informed consent forms (ICFs), clinical study reports (CSRs), investigator's brochures (IBs), and clinical data summaries for phase 1-phase 3 and post-marketing surveillance studies and as per agreed timelines.
  • QC and formatting of clinical modules of eCTD dossiers for global approval in developed and emerging markets with high quality and as per agreed timelines.
  • Ad-hoc writing support for clinical documents such a ICFs, CSRs and protocols
  • CSR publishing for regulatory submissions.
  • Ad hoc QC and formatting support for cross-functional teams in Medical Affairs and Clinical Development
  • Support in creating and/or updating SOPs, checklists, and templates.
  • Work collaboratively with other medical writers and cross-functional stakeholders within the Clinical Development function.
  • Support Group Lead in maintaining and tracking medical writer occupancy and resourcing
Qualifications
  • M Pharm with minimum 5 years of experience in document QC and formatting within the pharmaceutical industry
  • Excellent written, spoken, interpersonal and presentation skills
  • Proficiency in editing and formatting documents using Microsoft Office and Acrobat.
  • Good understanding of medical terms, clinical trials, and drug development process.
  • Ability to analyze and interpret scientific and medical data
  • Highly detailed orientated and excellent time management skills
Additional InformationAbout the DepartmentBenefits OfferedOur Work Culture

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