A large pharmaceutical company is looking to hire a Minimum 10 years of experience in the pharmaceutical industry
6 years of experience working in the regulatory submission processes, systems, and business requirements
Experience with content management systems (Documentum, Veeva, or similar)
Familiarity with SDLC and data administration concepts
Proven ability in change management and process improvement
Submission Content Source Management Business Operations Lead to backfill a key role within the regulatory systems team. This position functions as a Senior Business Analyst, supporting day-to-day operations and strategic oversight of content management systems used across regulatory functions.
Responsibilities
Serve as Business System Owner for submission content management platforms (Documentum, Veeva)
Own and define business requirements, make decisions on design topics, and lead process improvements
Interface with a large user base (~8,000 users) across preclinical, clinical, labeling, regulatory functions, etc.
Lead change management initiatives, including training and operational issue resolution
Collaborate with IT on system-related challenges and enhancements
Review and address issues related to submission content workflows
Understand and support the end-to-end regulatory submission process, including:
o Document production
o Content authoring
o Review and finalization
o Handoff to submission assembly teams
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
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- Minimum 10 years of experience in the pharmaceutical industry
- 6 years of experience working in the regulatory submission processes, systems, and business requirements
- Experience with content management systems (Documentum, Veeva, or similar)
- Familiarity with SDLC and data administration concepts
- Proven ability in change management and process improvement
- Green Belt certification or equivalent process management knowledge preferred
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.