Document Publisher - Specialist (Regulatory Affairs) Job - 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 Clinical, Regulatory and Global Safety submission components that adhere to both regulatory health authority and Merck guidelines for electronic/hardcopy submissions. The incumbent will support global process, ensuring submission readiness in the end-to-end document publishing process for submission components which includes formatting, publishing, quality control verification, and finalization. This requires collaborative interaction with content providers, submission managers, and submission assembly to ensure quality, right first time output and timeliness. Additionally, the incumbent may be involved in assisting with developing administrative documentation, providing inter-departmental and/or external stakeholder mentoring, as well as involvement with the testing and implementation of new systems, tools, and processes.
Primary responsibilities will include the following:
Publishing Support (~80%):
- Work closely with content providers to produce 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 publishing tools
- Provide authors with formatting assistance as needed, as well as guidance with regards to publishing and referencing processes
- Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of submissions
- Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies
Operational Support (~20%):
- Assist with the development of publishing processes and/or documentation as needed, including user acceptance testing for new or updated publishing tools
- Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders
- Identify activities and business processes in need of improvement and consider potential solutions or new ways of working using standard procedures
- HS diploma or equivalent, plus 10 years of regulatory publishing experience; or Associate’s degree, plus 6 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 a range of straightforward problems that arise within job responsibilities and expectations
- Effectively communicates difficult issues both verbally and in writing, and persuades others in straightforward situations
- Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
- Experience with the Liquent InSight Publisher application
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:Spclst, Regulatory Affairs
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Number of Openings: 2
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