Publishing Manager

Publishing Manager 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. Our key department values are: Passionate about partnership Quality without compromise Flexibility in a dynamic environment  In this role you will have the following responsibilities:  To provide effective management of the day-to-day activities of the Publishing group. This includes: Oversee the operational management of the publishing business, including achievement of team utilization and revenue targets. Serve as a senior level expert in consulting with clients, in performing publishing work and in peer-reviewing department work. Input into and/or review contracts, including consideration of objectives, scope, budget and timeline. Manage project scheduling and assignment of resources. Ensure the team's deliverables are complete, accurate, on time, of high quality, and electronically functional. Provide support on, or resolve, project issues Participate in the development and execution of a publishing sales and marketing plan, and to provide appropriate input to proposals/RFIs/bid defense presentations. Maintain a strong understanding of applicable regulatory guidelines. Ensure that the publishing systems are maintained and any upgrades are completed in line with appropriate procedures. Review and/or author standard operating procedures and other process documentation. Participate in the development and execution of a departmental business plan with clearly defined goals and objectives. Identify potential project problem areas and/or project-related regulatory compliance risks. Ensure the Publishing team is audit-ready at all times and participate in audits. Assist with qualification and management of third-party vendors. Working with internal study teams to determine/clarify project requirements and obtaining necessary information. To personally publish documents and submissions. This includes: Publishing documents and submissions in accordance with regulatory guidelines and according to contractual obligations. 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 project meetings in person or via teleconference. Perform QC of documents published by other writers. Achievement of individual utilization (billability) target. 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. Line management, training and mentoring of junior publishers. General operational assistance to the Publishing team. Active participation in department initiatives and process improvements. Participate in development of new publishing services. Compliance with department systems, e.g., project database, timesheets, training. Any other task deemed reasonable by department senior management. Additional duties as requested by department senior management.   Skills & experience required: Essential: Bachelor's degree in a life science, or equivalent. At least 7 years of experience as a clinical/regulatory Publisher in a Pharma company or CRO. Possess strong understanding of applicable international regulatory guidelines related to electronic and paper submissions. Expert knowledge of systems used within publishing eg Adobe Professional, ISI Toolbox, Lorenz DocuBridge, Liquent InSight Publisher, Documentum, Box Possess strong understanding of MS Office, especially MS Word. The ability to adopt new/changing regulatory guidance into existing processes. Excellent written and oral communication skills, problem-solving ability, strong interpersonal skills, and the ability to plan and organize are required. Demonstrated ability to prioritize and manage multiple projects and deadlines.  Preferred: Experience of working for a large CRO. Experience of leading and mentoring teams. Familiarity with Veeva Vault, Salesforce and Box.   Competencies: Able to recognize, exemplify and promote ICON's OwnIt culture and values of Accountability and Delivery, Integrity, Collaboration and Partnership. Able to work in a fast-paced, results-driven environment. Culturally aware and able to work comfortably within a global team. High degree of self-motivation and proactivity. Ability to work efficiently and independently under pressure. Ability to win the confidence and cooperation of colleagues. Ability to motivate others. Excellent oral communication skills, problem-solving ability, data?interpretation skills, interpersonal skills, planning and organization skills. ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment. EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin. Reference: 054080
Salary Range: NA
Minimum Qualification
8 - 10 years

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