Job Description

Business Analyst – System Process Design & Labeling Management Business Systems Operations

Seeking candidate with minimum 3 years of experience in Business Process Support for IT Applications that digitally enable Pharmaceutical Regulatory processes, preferably within the Labeling Operations space.
 

Education Min. Requirement: BS/BA or an equivalent degree in science, computer science, engineering or related discipline.
 

Responsibilities:

Active Project Coordination and Execution of System Enhancement, Maintenance, and Monitoring related initiatives.

Serve as a liaison between the Global Labeling Business Users of the System and the IT Partners for defining Business Requirements and ensuring the system is aligned.

Author, Develop and/or Update Training and Guidance Documentation (Training material updates, System SOPs, User Guidance Documents, System Process Diagrams, Demo Video Library, etc.)

Support for System Releases and preparation for future releases.

Support System Releases in collaboration with IT Business Partners including activities relating to Requirements Gathering, SDLC Documentation, Testing, Implementation, Deployment and Hypercare phases.

System Administrator activities supporting the alignment of the Global Labeling organization processes with the System Capability cross-functionally and cross-regionally.

Assist in Technical Related System User Support Cases with Issue Resolution/Identification of CAPAs and Enhancements, System Access Requests, and SharePoint Maintenance/Access Management.

Preferred System/Platform Experience:

Appian

JIRA

XRay

Confluence

Draw.io

MS Office

Preferred Experience and Skills:

Candidate must be familiar with IT System and Business Process support, preferably in the Regulatory and/or Labeling Operations space.

Must be capable/willing to represent the team, effectively prepare materials and facilitate meetings with our user community and drive project plans/deliverables.

Analytical and process minded with a desire for in depth learning of systems supporting complex Business Processes.

Ability to drive results based on specified objectives and capable of identifying/implementing improvement opportunities.

Demonstrate strong leadership and problem-solving skills and ability to gather relevant facts and distill information. 

Effortlessly works in a collaborative manner with cross-functional and cross-regional users and stakeholders.

Effective communication skills (written and spoken English). 

Ability to work cooperatively with others and provide significant contributions as a member of a team.

Strong organizational skills. 

The ability to be flexible and handle multiple tasks well, under pressure.

Demonstrate strong attention to detail.

Process-oriented with familiarity of GxP requirements and working in a highly regulated industry.

Experience with business process mapping and system design for workflow management tools is desirable.

Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is a requirement.

The successful candidate will primarily support Labeling Operations tools by enhancing and improving the system enabled business processes, support model and documentation to achieve heightened compliance, Right First Time and overall efficiency.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Required Skills:

Adaptability, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, Management Process, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Technical Writing

 Preferred Skills:

Job Posting End Date:

06/22/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R350940