Publishing Specialist

This is a rare opportunity to join our friendly global Publishing team which sits within ICON’s Clinical Research Services group. Our remit is to publish high quality documents supporting Phase I-III clinical studies and regulatory submissions.

Key department values are:

1.    Passionate about partnership

2.    Quality without compromise

3.    Flexibility in a dynamic environment

• We have an opening for a Publishing Specialist and in this role you will have the following responsibilities:
• Publishing documents and submissions in accordance with regulatory guidelines and according to contractual obligations.
• Perform QC of documents published by other team members.
• Assist with the remediation of Word documents to ensure proper format and compliance with applicable guidance documents.
• Attendance at internal and external project meetings in person or via teleconference.
• 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.
• Participate in development of new publishing services.
• Maintain a strong understanding of applicable regulatory guidelines.
• Achievement of individual utilization (billability) target.
• Active participation in department initiatives and process improvements.
• To keep senior management informed of project status and any issues that affect quality, timelines, and adherence to contractual obligations.
• Participation in internal and external audits.
• Compliance with department systems, e.g., project database, timesheets, training.
• Any other task deemed reasonable by department senior management.

Skills & experience required:

•      Bachelor’s degree or equivalent.
•      At least 1 year of experience as a regulatory Publisher in a Pharma company or CRO.
•      A good understanding of applicable international regulatory guidelines related to electronic and paper submissions.
•      A working knowledge of systems used within publishing eg Adobe Professional and MS Office, especially MS Word.

 Competencies:

• Recognize, exemplify and promote ICON's OwnIt culture and values of Accountability and Delivery, Integrity, Collaboration and Partnership.
• Able to adapt to new/changing regulatory guidance.
• Able to prioritize and manage multiple projects and deadlines.
• Able to work in a fast-paced, results-driven environment.
• Culturally aware and able to work comfortably within a global team.
• Able to work efficiently and independently under pressure.
• Excellent written and verbal English.
• Excellent communication skills, problem-solving ability, data interpretation skills, interpersonal skills, planning and organization skills, self-motivation and proactivity.