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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) .

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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 [email protected].