Submissions Sr. Publisher/Specialist

Merck is an innovative, global healthcare leader that is committed to improving health and well-being around the world.

Global Submissions Publishing (GSP) works closely with various stakeholders to ensure the timely completion of submission assemblies that adhere to both regulatory health authority and Merck guidelines for electronic/hardcopy submissions. The incumbent will support global process; executing end-to-end submission assembly which includes publishing, quality control verification, finalization and delivery. This requires collaborative interaction with component providers and submission managers to ensure quality, right first time output and timeliness. The incumbent will assume the role of lead publisher for larger, complex submissions (e.g. original marketing applications), which will include coordination of all publishing-related activities and delegation of activities to other publishers. Additionally, the incumbent will take the lead in the development of administrative documentation, provide inter-departmental and/or external stakeholder mentoring, and play an integral role in the testing and implementation of new systems, tools, and processes.

**Publishing Support:** * Work closely with submission managers to lead the production of high quality submission assemblies utilizing submission-ready documents that adhere to internal and external electronic submission guidelines * Ensure submission assemblies meet the level of technical integrity required for Merck and health authority validation tools * Assume the lead for training/mentoring internal and external publishing staff * Assist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right-first-time submission assemblies * Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions * Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies. **Administrative Support:** * Assume the lead role in the development of publishing processes and documentation, including user acceptance testing for new and updated publishing tools. Delegation of these project activities to publishers within the department as needed. * Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders * Evaluate activities and business processes, identify areas in need of improvement and take the lead in investigating potential solutions or new ways of working

**Education:** * Bachelor’s degree **Required:** * 5 years of regulatory publishing experience * In depth working knowledge of industry standard publishing systems and desktop applications including MS Word and Adobe Acrobat Professional * Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously * Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables * Demonstrates the ability to independently solve complex problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions * Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation * Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures **Preferred:** * 8 years of regulatory publishing experience * Expertise with the Liquent InSight Publisher application * Expertise with industry standard electronic document management system * Experience with project management and leading teams