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Job Description

A large life scicnces company is seeking a seasoned and strategic Program Manager to lead and manage a transformative Generative AI initiative, which involves a cutting-edge document authoring platform that is reshaping regulatory submissions. The ideal candidate will bring deep expertise in regulatory submission processes, strong program management capabilities, and a passion for innovation in digital transformation.

Key Responsibilities

- Lead the Generative AI program across workstreams, managing core teams, pilots, stakeholders, and roadmap execution.

- Collaborate with MRL leadership and cross-functional teams to align on timelines, deliverables, and resources.

- Drive adoption and pilot execution for key regulatory processes (e.g., marketing applications, PSUR, DSUR, CMC reviews), ensuring tracking and value reporting.

- Contribute to process redesign for an AI-enabled end-to-end workflow.

- Develop sponsor and leadership updates.

- Oversee creation of user guides, onboarding materials, and instructional content with business and IT.

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 opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their 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 or uniformed service member status, 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 [email protected] 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

- 8+ years of program/project management experience in a regulated industry (pharma/biotech preferred)

- Deep understanding of eCTD structure, regulatory submissions, and documentation standards

- Experience with pilot planning, metrics tracking, and business case development

- Proven success managing cross-functional teams

- Strong communication, stakeholder management, and organizational skills - PMP or similar certification

- Experience with digital tools and platforms, ideally GenAI or automation technologies