This is a rare opportunity to join our friendly global Medical Writing team 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

Responsibilities:

• Author and perform QC of Patient narratives.
• Work with internal study teams to determine/clarify project requirements and obtain necessary information.
• Track and record 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.
• Attend internal and external project meetings via teleconference/Webex.
• Write documents according to agreed contractual obligations and timelines using client or ICON templates and style guides, adhering to regulatory or other guidance.
• Incorporate review comments from internal and external reviewers, including management of multiple sets of comments.
• Perform QC of documents written by other writers.
• Keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.
• Achieve individual utilization (billability) target.
• Comply with department systems, e.g., project database, timesheets, training.
• Provide general operational assistance to the Medical Writing team.
• Prepare and QC other document types, if required.
• Actively participate in department initiatives and process improvements.
• Perform 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.
• Ability 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 and written English, with strong organization, syntax, grammar, clarity, focus, and messaging skills requiring minimal editing/rewriting.
• Excellent attention to detail.

Preferred:

• Good experience working on Oncology Narratives.
• Experience working for a large CRO.
• Familiarity with Veeva Vault, Salesforce, and Box.

Competencies:

• Able to recognize, exemplify, and promote ICON’s Own It culture and values of Accountability & Delivery, Integrity, Collaboration, and Partnership.
• Proactive, gracious, and collaborative communication skills.
• Able to work in a fast-paced, results-driven environment.
• Culturally aware and able to work comfortably within a global team.

Application Link