Sr. Specialist, Submissions Publisher (Regulatory Affairs) Job Rahway United States,
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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.
Primary responsibilities will include the following:
Assembly 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.
- 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
- Bachelor s degree
- 5 years of regulatory assembly 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
- 8 years of regulatory publishing experience
- Knowledge and experience with the Liquent InSight Publisher application
- Knowledge and experience with industry standard electronic document management system
- Experience with project management and leading teams
Our employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.
Job: Regulatory Affairs Generic
Job Title:Sr. Spclst, Regulatory Affairs
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Regulatory Affairs, Law, Compliance, Administrative Assistant, Animal Health, Legal, Administrative, Veterinary
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