Sr. Document Publisher-Specialist - Regulatory CMC 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.
Regulatory Content Management (RCM) works closely with various stakeholders to ensure the timely completion of Chemistry, Manufacturing and Controls submission components that adhere to both regulatory health authority and Merck guidelines for electronic/hardcopy submissions. The incumbent will support global process by ensuring submission readiness in the end-to-end document publishing process for submission components which includes formatting, publishing, quality control verification, finalization and DMS system support. This requires collaborative interaction with component providers and submission managers to ensure quality, right first time output and timeliness. Additionally, the incumbent will assume the role of lead publisher for large, complex submissions, which will include attending submission team meetings and coordinating document-level support with assigned publishers. 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:
Publishing Support (~60%):
- Work closely with content providers to lead the production of high quality submission-ready documents that adhere to internal and external electronic submission guidelines
- Ensure submission documents 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
- Provide back up support to the submission teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right-first-time document publishing
- 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.
Operational Support (~40%):
- 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
- Required: Associate s Degree, plus 12 years of regulatory publishing experience or Bachelor s degree, plus 5 years of regulatory publishing experience
- In depth working knowledge of industry standard publishing systems, electronic document management 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 and drive results
- Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
- Expertise with the Liquent InSight Publisher application
- Experience with project management and leading teams
- Experience with Chemistry, Manufacturing and Controls Regulatory documentation
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.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
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
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Regulatory Affairs, Law, Compliance, Document Management, Animal Health, Legal, Technology, Veterinary
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