Medical Writer I

The role:

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 clinical studies and regulatory submissions.

Our key department values are:

1. Passionate about partnership

2. Quality without compromise

3. Flexibility in a dynamic environment

In this role you will have the following responsibilities:

• Primary responsibility would be to author and perform QC of Patient narratives.

• 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 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/master’s degree in pharmacy/life science, or equivalent.

• At least 2-3 years of experience as a Narrative/clinical/regulatory Medical Writer.

• 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.