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Job Details

Merck & Co, Inc

Senior Business Validation Lead (Business Product Analyst) ( MERCUSR173192ENUS)

Business Development




Rahway, New Jersey, United States

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

The Senior Business lead will work closely with Technical partners, cross functional teams to develop and successfully execute the business strategy and technology innovations of the assigned capability area, including but not limited to the design, development and deployment of the process using the application, within the clinical product line model.

The role is responsible to understand the functional strategy, drive the prioritization of projects, ensure that projects align with the business roadmap that best provides maximum return on investment, and overall business strategy. It is a role requiring strong business analyst skills, issue resolution, creativity and attitude of result driven. The role will ensure compliance to our Company, local laws and agency regulations and related guidance around technology.

  • Work with the business stakeholders to define and collect user stories, document process maps, translate user stories to functional specifications

  • Collect, assign, track, and prioritize requests from users requiring modifications (upgrades or bug fixes) to existing systems; develop business case in collaboration with process owners/stakeholders and IT for new solutions.

  • Present change requests for upgrades/bug fixes/data changes and coordinate release planning and assessment for the business in collaboration with IT.

  • Investigation and problem solve technical issues as part of the problem resolution process to drive Root cause Analysis

  • Ensure business needs and criticality of functionality are correctly documented in SDLC documentation. Review and approve appropriate validation documentation.

  • Represent business users by being a voice of reason during discussions with the system vendor & IT Product Manager to ensure right enhancements are proposed & identified.

  • Partner with the IT Product Manager & Business Product Owners to enable new system enhancements.

  • Work with solution provider to ensure appropriate enhancements are incorporated in vendor roadmap that not only supports current process/needs but also future vision and innovative technology options.

  • Ensure business has appropriate training materials (training manuals/e-learnings/Job Aids) and process documentation (SOP's/Guidelines) to support the use of the system. Periodically assess and update if needed.

  • Facilitate trainings to ensure users are appropriately trained in the use of the system.

  • Communicate system functionality changes and impact to existing processes to the users in a concise and timely manner.

  • Communicate and coordinate the implementation of system changes to Business Process/Sub-process Owners, requestors, and stakeholders.

  • Collect user stories, document process maps, translate user stories to functional specifications

  • Contribute to the ongoing development of global standardized procedures for the use and maintenance of the application across functional groups and countries.

  • Monitor support metrics and performance of the system on routine basis to assess needs for improvements (added resources or technology improvements). Work with business to ensure optimized use of product features.

  • Collaborate with IT to ensure internal Service Level Agreement (SLA) is created for the application, reviewed and updated once a year.

  • Partner with the IT Support Lead to coordinate downtime communications – content, timing, contacts, etc.

  • Work with IT and support team to create user provisioning and deprovisioning process

  • Periodically audit user access to system to ensure only intended users have access.

  • Manage UAT related activities such as assessing UAT needs, developing and communicating high-level UAT plans.

  • Coordinate UAT by identifying testers for UAT, ensuring proper training is completed, develop test cases, track issues during testing and ensure proper documentation is completed prior to deployment.

  • Ensure proper process and guidelines are in place to share and exchange data between applications & apply record retention policy.

  • Responsible for completion of risk and privacy assessments and ensure adherence to risk and privacy policies.

  • Act as primary business contact for assigned systems during audits and inspections and collaborate with IT and process owners to respond to all audit and inspection related requests in a timely manner.

Minimum required education:

  • BA/BS degree with 5 or more years experience

​Required experience and Skills:

  • Experience in a lead role executing/overseeing simple-moderate level projects or organizational improvement initiatives preferred.

  • Understanding of drug development - safety, clinical trials, trial design, data management, trial operations, privacy, ICH, and GCP required.

  • Proven track record in translating business strategies into clearly defined implementation roadmaps.

  • Project Management experience is required.

  • Strong Build team building and partnership management who is able to influence ideas and drive discussions

  • Demonstrates the courage to assume personal accountability in challenging situations

  • Demonstrates drive/passion/willingness to introduce improvements

  • Must have excellent oral and written communications skills - able to present information confidentially and effectively to leadership, peers, and team.

  • Ability to influence without authority and successfully manage various level stakeholders.

  • Prior exposure to or demonstrated the use of design thinking methodologies is desirable.

  • At least five years of experience in technology implementation, business process improvement, project management, systems analysis or systems maintenance/support

  • Basic understanding of System and UAT testing & providing training to user communities.

  • Critically evaluate process implications of system changes and deal with conflict and bring to resolution.

  • Knowledge in Platform and system design management

  • Able to identify critical input and outputs that drive business processes and dependencies on process (workflow) vs. technology (dataflow).

  • Working knowledge of databases preferred, SQL or other database/query tools a plus

  • Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staffs.

  • Strong process improvement and business analyst skills

  • Knowledgeable in different methodologies to design, develop and test like Agile, SDLC and waterfall methodology

  • Skilled in MS Access, MS Excel,

  • JIRA and confluence experience is preferred.

  • Recognized as “team player”, Possess good project management skills and Committed to continuous improvement.

  • Analytical ability, good judgment, ability to multi-task.

  • Ability to proficiently interact with all levels of management and exert influence to achieve results.


We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.


In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:



No relocation

VISA Sponsorship:


Travel Requirements:


Flexible Work Arrangements:

Telecommuting, Work Week


Valid Driving License:


Hazardous Material(s):

Number of Openings:


Requisition ID:R173192