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Job Information

Merck Organon - Senior Specialist, Regulatory Technology Products in Lansdale, Pennsylvania

Job Description

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

The Senior Specialist, Regulatory Technology Products will report directly to the Director of Regulatory Business Technology and will be a key member of the Organon R&D Business Technology team.

This position is responsible for the vision and prioritization (via translated business needs) of new and/or enhancements to technology products or platforms. The position is accountable for both technical and business value delivery. As such, the individual must synthesize business strategy goals, challenges/pain points, IT enterprise and business process architecture, and external environment changes to delivery valuable technology solutions. Organon will be a new company: the individual must embrace ambiguity and have an entrepreneur’s/founder’s mindset.

Primary Activities:

  • Partner directly with Regulatory business functions, technology subject matter experts, solution specialists, and other team members to understand key business process and how to implement technology solutions effectively and efficiently in alignment with business and BT strategy

  • Write and prioritize backlog user stories/requirements, focusing on business and technical requirements

  • Groom best-in-class product features with detailed analysis of impact vs. value

  • Understand and manage down technical debt for the product/platform

  • Shape and own the product/platform roadmap and vision

  • Work within a cross-functional team to clarify requirements and delivery expectations with business stakeholders

  • Meet all compliance obligations through tasks such as requirements elicitation and documentation, User Acceptance Test planning and coordination, requirements traceability, and software development lifecycle (SDLC) best practices.

  • Work directly and collaboratively with business and technology stakeholders across disciplines and at all levels

  • Help Craft Objectives & Key Results (OKRs) for the product/platform

  • Perform vendor oversight as necessary

Required Experience & Skills

  • A minimum of 5 years of IT Product Owner or IT Analyst experience.

  • Domain knowledge of Regulatory R&D processes and/or technologies

  • Demonstrated ability to succeed in a complex and dynamic work environment. Proven ability to manage multiple priorities and tasks simultaneously

  • Natural curiosity and a desire to do things differently

  • Strong commitment to tangible and valuable outcomes

  • Experience creating user stories / requirements, use cases, process flows, wireframes and data mappings encompassing facilitation, negotiation, and trade-off analysis

  • Ability to adapt and rapidly learn new technologies and apply their findings to solve key business challenges

  • Strong analytical and problem-solving skills balanced with a creative mindset

  • Must be able to develop and articulate a plan of action, whether in support of strategy development or planning a roadmap. This plan must be clear, compelling and understandable, and flow in a logical fashion with supporting rationale as appropriate.

  • Strong written & verbal communication skills (English) and ability to foster strong partnerships with global colleagues.

  • Strong interpersonal skills including teamwork, facilitation, and the ability to influence.

  • Experience in creating and reviewing IT Software Development LifeCycle (SDLC) documentation.

Preferred Experience & Skills

  • Experience with architecture, integration, interfaces, portals, and/or analytics

  • Experience with Documentum, PAREXEL, Veeva Vault RIM, Cognos Reporting tools, workflow tools (Appian, TIBCO, Active Matrix, UIpath), and API frameworks (Apigee)

  • Experience with validated health authority regulatory (HAR) capabilities, SDLC, inspection and audits

  • Experience working with on premise, Cloud capabilities, and software as a service (SaaS)

  • Agile development experience preferred

  • Experience working with innovative experiments, specifically contributing to idea generation, idea incubation, and/or experimentation

  • Demonstrated ability to understand business strategy, including goals and outcomes, and the end-to-end processes, capabilities and applications needed to achieve the business strategy

  • Ability to develop the strategy for application development and define the technical infrastructure to support that strategy.

Education Minimum Requirement:

  • Bachelor’s degree or above. Concentration in Engineering, Sciences, Information Systems or related field preferred.

Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.



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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

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

EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:




VISA Sponsorship:


Travel Requirements:


Flexible Work Arrangements:

Remote Work, Telecommuting


1st - Day

Valid Driving License:


Hazardous Material(s):

Number of Openings:


Requisition ID: R94949