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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:

Passionate about partnership
Quality without compromise
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.

A better career. A better world. A better you.

Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
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Medical Writer I

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