Job Description

Business Analyst/Project Manager - System Process Design & Labeling Management Business System Operations
 

Seeking candidate; BS with 5-10 years of pharmaceutical regulatory experience, in Project Management and Business Process Support for IT Applications that digitally enable Pharmaceutical Regulatory processes. Preferred 3+ years Project Management related experience.

Education Min. Requirement: BS degree in science, computer science, engineering, or related discipline.

MS degree is preferred.

Job Description:

We are seeking an experienced Business Analyst with experience as a Project Manager to support our System Process Design & Labeling Management Business Operations team. The role will be tasked with Project Management for cross-functional initiatives in addition to supporting Labeling Operations applications in a senior level Business Analyst capacity.
 

The successful candidate will play a critical role in helping to structure/implement project plans, define deliverables, coordinate SME involvement, and facilitate meetings/workshops. Additionally, the candidate will assist in aligning standards for documenting current state processes, conducting process assessments, visualizing future state processes, and contributing to setting the framework for future system process design. Additionally, the successful candidate will assist with application specific Business Analyst related activities within the team, as assigned (e.g., Support System Releases in collaboration with IT Business Partners including activities relating to Requirements Gathering, SDLC Documentation, Testing, Implementation, Deployment and Hypercare phases).

Responsibilities:

Project Planning: Collaborate with the team to structure project plans based on the established strategy. Help define project scope, objectives, and drive completion of deliverables.

Deliverable Definition: Work closely with the team lead to define the deliverables, establish target timelines, and assign responsibilities.

SME Involvement: Assist in identifying subject matter experts (SMEs) relevant to the project(s) and coordinate involvement in workshops and other project activities, ensuring their expertise is leveraged effectively.

Meeting/Workshop Strategy: Develop a meeting/workshop strategy in collaboration with team. Coordinate logistics, facilitation, and invite identification to ensure productive and inclusive sessions.

Process Documentation: Assist in setting the standards for documenting the current state processes and working closely with SMEs. Facilitate/Conduct tactical-level process step assessments to identify gaps and areas for leveraging User Experience improvements for applications.

Future State Visualization: Collaborate with stakeholders to visualize and define future state processes. Use industry best practices and innovative approaches to develop a process enablement roadmap that supports established objectives.

Solution Evaluation and Design: Contribute to setting the framework for solution evaluation and design activities. Ensure effective implementation of user-centered design principles and evaluation methodologies during the evolution of the project(s).

Experience/Skills:

BS with 5-10 yrs or MS with 5+ years of pharmaceutical regulatory experience, including 3+ years project management related experience.

Project management experience and/or certification.

Proficient skills with software including MS Office and Confluence. Power Apps and Power BI experience preferred.

Experience with Process Flow/Modeling tools preferred (e.g., Draw.io)

Excellent communication and interpersonal skills.

Proven experience negotiating, managing change, goal setting, planning and organizing, teamwork, addressing challenging situations and understanding technical information.

Able to demonstrate strong ability to work independently and accomplish goals in team settings; experience in leading task forces for assigned work. Proven ability to effectively keep projects and assignments on track or properly rescoped with management approval. 

Knows when and how to speak up and appropriately raise issues to the team and management.

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, Adaptability, Applied Engineering, Audits Compliance, Business Management, Business Operations, Business Systems, Computer Science, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Management Process, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Pharmacy Regulation, Process Evaluations, Process Flow Documentation, Process Improvements, Project Management, Project Planning, Project Scoping, Quality Process Improvement, Regulatory Affairs Compliance {+ 5 more}

 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:R350937