Senior Medical Writer
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.
Application process
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