Job Description

The Position

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 individual is responsible for providing support and business/technical analysis efforts for the Regulatory systems, including requirements gathering, support, delivery, enhancement and vendor management.  This individual should have a familiarity with core Regulatory processes as well as BTS core processes such as change management, service management, SDLC, and incident management.  This individual should have strong collaboration and communication skills to work with business clients, our service management team, and our vendors to provide the best possible responses and services to our business clients.

This individual should have experience with Compliance, Computer Systems Validation, and Data Integrity and how these are implemented day-to-day in the work BTS does to deliver and support BT platforms for the business.  This individual will work closely with the Regulatory Value Team in the overall management, delivery, and support of our Regulatory platforms. 

Responsibilities:

Ensure top tier support to business clients for Regulatory systems.Manage the Regulatory platforms day to day – including delivery and supportEstablish and review metrics for support and overall platform operationsWrite and prioritize backlog user stories/requirements, focusing on business and technical requirements.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 to implement new solutions and updates to our current Regulatory solutions

Required Education, Experience, and Skills

Bachelor’s degree or equivalent in Engineering, Sciences, Information Systems, or related field preferred.At least 2 years of relevant experience in business analysis, working with business teams, building and delivering effective business processes aligned to solutions, providing IT support.Demonstrated ability to succeed in a complex and dynamic work environment.   Proven ability to manage multiple priorities and tasks simultaneously.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.Strong interpersonal skills including teamwork, facilitation, and the ability to influence.Experience in creating and reviewing IT Software Development LifeCycle (SDLC) documentation.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) is a plus.

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Preferred

Agile development experience preferred.Domain knowledge of Regulatory R&D processes and/or technologies.

Secondary 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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

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. 

Annualized Salary Range

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

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

10%

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R535203