Publishing Specialist

This is a rare opportunity to join our friendly globalPublishing team which sits within ICON's Clinical Research Services group. Ourremit is to publish high quality documents supporting Phase I-III clinicalstudies and regulatory submissions.
Key department values are:
1. Passionate about partnership
2. Quality without compromise
3. Flexibility in a dynamicenvironment
We have an opening for a Publishing Specialist and in this role you will have the followingresponsibilities:
Publishing documents andsubmissions in accordance with regulatory guidelines and according tocontractual obligations.
Perform QC of documentspublished by other team members.
Assist with theremediation of Word documents to ensure proper format and compliance withapplicable guidance documents.
Attendance at internal andexternal project meetings in person or via teleconference.
Tracking and recording progressagainst contracted hours/budget using financial tracking tools and thedepartment's project database. Early flagging to management of projects not ontrack and facilitation of the Change Order process.
Participate in development ofnew publishing services.
Maintain a strong understandingof applicable regulatory guidelines.
Achievement of individualutilization (billability) target.
Active participation indepartment initiatives and process improvements.
To keep senior managementinformed of project status and any issues that affect quality, timelines, andadherence to contractual obligations.
Participation in internal andexternal audits.
Compliance with departmentsystems, e.g., project database, timesheets, training.
Any other task deemedreasonable by department senior management.
Skills & experiencerequired:
Bachelor's degree or equivalent.
At least 1 year of experience asa regulatory Publisher in a Pharma company or CRO.
A good understanding ofapplicable international regulatory guidelines related to electronic and papersubmissions.
A working knowledge of systemsused within publishing eg Adobe Professional and MS Office, especially MS Word.
Recognize, exemplify andpromote ICON's OwnIt culture and values of Accountability and Delivery,Integrity, Collaboration and Partnership.
Able to adapt to new/changingregulatory guidance.
Able to prioritize and managemultiple projects and deadlines.
Able to work in a fast-paced,results-driven environment.
Culturally aware and able towork comfortably within a global team.
Able to work efficiently andindependently under pressure.
Excellent written and verbalEnglish.
Excellent communication skills,problem-solving ability, data interpretation skills, interpersonal skills, planningand organization skills, self-motivation and proactivity.

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