Medical Writer I
About the role
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- Passionate about partnership
- Quality without compromise
- Flexibility in a dynamic environment
- 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.
- 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.
- Experience of working for a large CRO.
- Familiarity with Veeva Vault, Salesforce and Box.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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