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Job Details

Business Technology Regulatory Product Owner


Business Analyst


Jersey City, New Jersey, United States

Job Description

The Position

The Business / Technical Analyst - Regulatory Technology Products will report directly to the Director of Regulatory Business Technology and will be a key member of the Organon Research and Development (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 for the Organon R&D Regulatory area. 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.


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

  • Groom best-in-class product features with detailed analysis of impact versus 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 Education, Experience & Skills

  • Minimum of Bachelor’s degree with a Concentration in Engineering, Sciences, Information Systems, or related field preferred.

  • At least five 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, 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 Content Management platforms (Documentum, Veeva Vault RIM), Health Registration Management & Publishing (Calyx, Ennov, Veeva Vault RIM), PowerBI Reporting tools, and workflow/automation tools (PowerAutomate, UIpath).

  • Experience with validated Health Authority Regulatory 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.

Secondary Language(s) Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully
Organon LLC., 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.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:



No relocation

VISA Sponsorship:


Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.


Flexible Work Arrangements:

Flex Time, Telecommuting


Valid Driving License:

Hazardous Material(s):

Number of Openings:


Requisition ID:R526604