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Scientific Communications Expert

2 weeks ago

Mumbai, Maharashtra, India Fortrea Full time

Job Summary

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We are seeking a highly skilled Content Writer to join our team at Fortrea. As a key member of our scientific communications team, you will be responsible for the preparation of clinical study protocols and clinical study reports (CSRs), as well as other clinical documents.

The ideal candidate will have excellent writing and communication skills, with the ability to work independently and collaboratively as part of a team.

Key Responsibilities

  • Preparation of protocols and CSRs, including interpretation of clinical data and statistical results as appropriate.
  • Work under guidance from colleagues to assist development of protocols, CSRs, and other clinical documents on complex studies and programs.
  • Prepare and review patient safety narratives.
  • Lead project management and coordination of narrative projects.
  • Oversee and coordinate other writers on CSR appendices compilation.
  • Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
  • Participate in review of Statistical Analysis Plan (SAP) and Tables, Figures, and Listings (TFLs) to ensure appropriate data presentation for CSR purposes.
  • Incorporate internal and/or external review comments on clinical documentation.
  • Prioritize and forward plan workload to a high standard; advise Management of problems promptly.
  • Participate independently in internal and external client meetings.
  • Lead meetings as appropriate.
  • Responsible for project coordination and adherence to project timelines and budget.
  • Identify ways to improve the efficiency and quality of work processes.
  • Mentor Associate Medical Writers and Medical Writer I, as appropriate.
  • Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience.
  • Provide training to Medical Writers and other staff as appropriate.
  • Represent department in audits and inter-department working groups.
  • Comply with Fortrea internal processes and procedures.
  • Perform other duties as assigned by Management.