Merck Organon - Senior Specialist, Regulatory Technology Products in Lansdale, Pennsylvania
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.
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.
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Flexible Work Arrangements:
Remote Work, Telecommuting
1st - Day
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Number of Openings:
Requisition ID: R94944
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