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Sr Medical Writer

India-Chennai
Permanent
Reference: 055299
Description
Medical Writer I – Specification
 
This is a rare opportunity to join our friendly global Medical Writing team which sits within ICON’s Clinical Research Services group. Our remit is to produce high quality documents supporting Phase I-III clinical studies and regulatory submissions.
 
Our key department values are:
 
  1. Passionate about partnership
  2. Quality without compromise
  3. Flexibility in a dynamic environment
 
We have an opening for a Medical Writer I.
 
In this role you will have the following responsibilities:
 
  • Preparation and QC of clinical and regulatory documents including protocols, clinical study reports, narratives and safety reports. This includes:
    • Working with internal study teams to determine/clarify project requirements and obtaining necessary information.
    • Tracking and recording progress against contracted hours/budget using financial tracking tools and the department’s project database. Early flagging to management of projects not on track and facilitation of the Change Order process.
    • Attendance at internal and external projects meetings via teleconference/Webex.
    • Writing of documents according to agreed contractual obligations and timelines using client or ICON templates and style guides, and adhering to regulatory or other guidance.
    • Incorporation of review comments from internal and external reviewers, including management of multiple sets of comments.
    • Perform QC of documents written by other writers.
  • To keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.
  • Achievement of individual utilization (billability) target.
  • Compliance with department systems, e.g., project database, timesheets, training.
  • General operational assistance to the Medical Writing team.
  • Preparation and QC of other ad hoc document types, if required.
  • Active participation in department initiatives and process improvements.
  • Any other task deemed reasonable by department senior management.
 
Skills & experience required:
Essential:
  • Bachelor’s degree in a life science, or equivalent.
  • At least 1 year of experience as a clinical/regulatory Medical Writer or other technical/scientific writing role.
  • Able to assimilate and summarize large volumes of scientific data accurately, clearly and concisely.
  • Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat and Outlook. Able to rapidly learn to use bespoke in-house and client toolbars.
  • Excellent verbal English.
  • Excellent written English, e.g., organization, syntax, grammar, clarity, focus, messaging that requires minimal editing/rewriting.
  • Excellent attention to detail.
Preferred:
  • Experience of working for a large CRO.
  • Familiarity with Veeva Vault, Salesforce and Box.
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