Job Description
The Position
Although one or more potential candidates for this position have been identified, we will consider applications from any interested applicants."
The role of Senior Specialist, Business Technology Medical Affairs will report to the headquarters Director, Research and Development (R&D) Business Technology and will be a key member of the R&D Business Technology Services team.
The position will lead program management, technical architecture, and business analysis efforts for Medical Affairs systems, driving seamless solution delivery, strategic enhancements, and effective vendor coordination across a complex global environment. This role is pivotal in aligning IT capabilities with business objectives, driving innovation, and maintaining compliance across integrated platforms.
This individual is responsible for overseeing the end-to-end lifecycle of Medical Affairs IT initiatives, including requirements gathering, solution delivery, ongoing support, and enhancement planning. Partner closely with Medical Affairs business leads, Pharmacovigilance, Product Quality Compliance, CRM, and the Organon Service Centre leads to ensure systems are integrated, optimized, and aligned with Organization roadmap. Apply the knowledge of change management, service management, SDLC, and incident management to ensure operational excellence and regulatory compliance. Drive continuous improvement by collaborating with development partners to design and deliver scalable solutions for the Medical Affairs Value Team. Serve as a trusted liaison between business clients, service management teams, and vendors, ensuring high-quality service delivery and responsive support. Implement best practices in Computer Systems Validation (CSV), Data Integrity, and Compliance, embedding these principles into daily operations and platform delivery.
Responsibilities
Lead the planning, execution, and governance of Medical Affairs IT programs, ensuring alignment with strategic business goals and global standards.
Oversee the full lifecycle of initiatives—from requirements gathering and solution design to delivery, support, and enhancement.
Conduct in-depth analysis of business needs and translate them into functional and technical requirements.
Collaborate with stakeholders to define user stories, process flows, and system specifications that drive value.
Partner with Medical Affairs, Pharmacovigilance, Product Quality Compliance, CRM, and Organon Service Centre teams to ensure seamless integration and optimization of systems.
Facilitate alignment between IT capabilities and the organization’s roadmap through effective stakeholder engagement.
Apply expertise in change management, service management, SDLC, and incident management to maintain high standards of performance and reliability.
Monitor and improve service delivery metrics, ensuring responsiveness and quality in support operations.
Apply expertise in change management, service management, SDLC, and incident management to maintain high standards of performance and reliability.
Monitor and improve service delivery metrics, ensuring responsiveness and quality in support operations.
Manage relationships with external vendors and development partners to ensure timely delivery of scalable, compliant solutions.
Oversee vendor performance and ensure adherence to contractual obligations and service-level agreements
Implement and uphold best practices in Computer Systems Validation (CSV), Data Integrity, and regulatory compliance across all Medical Affairs platforms.
Ensure that IT solutions meet internal audit standards and external regulatory requirements.
Identify opportunities for innovation and process enhancement within Medical Affairs systems.
Lead initiatives that improve system usability, performance, and business impact.
Act as a trusted advisor to business clients, providing strategic guidance and responsive support.
Communicate effectively across technical and non-technical audiences to foster collaboration and transparency.
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 Medical Affairs systems
Required Education, Experience, and Skills
Bachelor’s degree or equivalent in Engineering, Sciences, Information Systems, or related field preferred.
At least five years of relevant experience in Solution Architecture, Program management, working with business teams, building and delivering effective business processes aligned to Medical Affairs solutions
Providing IT support for Medical Affairs and coordinating with development partners, Pharmacovigilance, Product Quality Compliance, CRM and Organon Service Center (OSC), AI, Automation and MuleSoft teams on future enhancements
Demonstrated ability to lead complex, cross-functional initiatives that align IT capabilities with business objectives, delivering measurable outcomes.
Adept at navigating dynamic, fast-paced environments with competing priorities; excels in managing multiple programs and stakeholders simultaneously.
Skilled in translating business needs into actionable deliverables—user stories, use cases, process flows, wireframes, and data mapping while facilitating trade-off discussions and stakeholder alignment.
Quick to learn and apply emerging technologies to solve business challenges; brings a balance of technical depth and business acumen
Strong problem-solving skills with the ability to think both analytically and innovatively to drive continuous improvement
Strong interpersonal and communication skills with a proven ability to influence, facilitate, and build consensus across diverse teams.
Experience in authoring and reviewing documentation aligned with IT Software Development Life Cycle (SDLC) standards and regulatory expectations.
Strong commitment to tangible and valuable outcomes.
Experience in creating and reviewing IT Software Development LifeCycle (SDLC) documentation.
Three to four years of Project management experience using MS Project, Smartsheet and Jira.
Preferred Experience and Skills
Agile development experience with Safe certification preferred.
Domain knowledge of Medical Affairs, Pharmacovigilance
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.
US and PR Residents Only
For more information about personal rights under Equal Employment Opportunity, visit:
Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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)
$103,100.00 - $175,300.00Annualized 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%Flexible Work Arrangements:
Flex Time, HybridShift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1