Insight Global
Job Description
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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .
Skills and Requirements
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 null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .
Skills and Requirements
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 null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.