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:
- Passionate about partnership
- Quality without compromise
- 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.