Merck Organon - Associate Director, Business System Oversight HRM in Salt Lake City, Utah
Reporting to the Director of R&D Business Systems Regulatory, Health Registration Management (HRM), the Associate Director of Regulatory Business Systems Oversight, HRM, is accountable for providing operations of business systems established for Regulatory. This role is accountable for ensuring regulatory systems are fully supporting all phases of product registration and lifecycle management for organon products. This role drives strategic activities for regulatory business system capabilities in an alignment with the Executive Director of R&D Business Systems Regulatory. This role collaborates with the many stakeholders and users of the regulatory capabilities to plan and execute the operational business system activities.
The Associate Director of Regulatory Business System Oversight, Health Registration Management (HRM) is accountable and responsible for the following activities:
Leads projects and initiatives supporting the long-term vision and strategy for regulatory business systems, helping to drive business outcomes.
Ensures that tools, systems and procedures are align with business process and information needs for Chemistry Manufacturing Controls (CMC) and Manufacturing customers.
System improvement initiatives with Regulatory Information Management Systems, i.e. enhancements and hotfix implementations
Collaborates with these functional area contacts, process owners and IT product/account managers to develop business-related SLC documentation.
Interface with CMC and MANUFACTURING DIVISON to understand, support and communicate the strategy and needs of that team as it impacts HRM data, systems and processes
Operates the business system capabilities of the regulatory organization focused on registration management, partnering with external parties and other internal R&D functions where appropriate.
Provides industry expertise and practical knowledge of current and emerging technologies and processes approaches within regulatory, including, but not limited to, registration, dossier publishing, and produce lifecycle management.
Influences leaders to see new opportunities for enhanced regulatory business system capabilities.
Proactively identifies new capabilities and enhancements that will improve regulatory and broader R&D operations.
Functions as a contributing member of initiative teams which represents the strategic operations organization at both internal and external forums on regulatory business system capabilities for product registration and publishing as a representative of HRM
Investigate, analyze and document user requirements, including but not limited to requirements definition, solution design, configuration and administration plan.
Support system validation activities such as producing user acceptance/performance qualification testing scripts, executing the test scripts and monitoring.
Ensure high ethical standards and a culture that values honesty, integrity, and transparency.
Education Minimum Requirement:
- Bachelor’s degree with 6+years of industry experience within a research and development organization, with 3 years in Regulatory Information Management (RIM) systems experience with technical systems in a regulated environment or Master’s Degree and a minimum of 4 years of industry experience with 3 years in RIM Systems area and experience with technical systems in a regulated environment
Required Experience and Skills:
3+ years of experience in a regulated research and development environment, preferably in the regulatory affairs product registration and lifecycle management domain
Experience with Regulatory Information Management Systems with COTS applications such as Liquent InSight Suite, Veeva RIM System and ArisG
Broad range of knowledge of regulatory processes
Knowledge of Regulatory Filing procedures and/or Health Authority Registration process
Ability to lead and influence others outside of a direct reporting relationship
Broad organizational awareness and knowledge of touchpoints/interdependencies
Must have proven track record to be able to think critically, strategically, independently and problem solve
Must have high level of motivation, drive, and demonstration of Organon leadership values
Excellent written and verbal communication skills including ability to write clearly and concisely
Top notch interpersonal skills in difficult situations
Driver of change and innovation
Ability to work seamlessly with all levels of personnel
Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
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.
At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.
At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.
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Flexible Work Arrangements:
Remote Work, Telecommuting
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R110335