Medical Writer I

1 - 6 years

3 - 8 Lacs

Posted:6 hours ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

  • Candidate with min 6 months - 1year of experience of clinical Trial Disclosure or CTT
  • Should have good experience protocol registration, result registration
  • Should have excellent communication and client mgt experience.
  • Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision.
  • Develops or supports, a variety of documents that include but not limited to:
  • Clinical study protocols and clinical study protocol amendments;
  • Clinical study reports;
  • Patient narratives;
  • Investigator brochures.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required.
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
  • Performs on-line clinical literature searches, as applicable.
  • Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
  • Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
  • Completes required administrated tasks within the specified timeframes.
  • Performs other work-related duties as assigned. Minimal travel may be required (less
    than 25%).

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