Senior Manager, Regulatory Operations, Business Excellence

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November 1

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BeOne Medicines

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BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

10,000+ employees

Founded 2010

📋 Description

• Lead process improvement/optimization projects from inception to implementation to improve processes and the efficiency within the organization. • Monitor and support use, adoption, and improvement of GROSI programs, systems, policies, procedures, and controls. • Work with a diverse team comprised of cross functional stakeholders and team members to ensure processes and procedures remain in a compliant state. • Provide project management support on execution of the implementation plan working closely with cross-functional stakeholders. • Support process, mapping activities, maintain trackers and publish metrics reports. • Provide timely and accurate updates on projects and activities as required by leadership as well as present strategic vision and status updates to senior management. • Investigate current workflows and process-related pain-points and propose solutions from current to ideal end-state; develop and present proposals to key stakeholders and leaders for buy-in on proposed end-state. • Measure the efficiency and utilization of newly implemented workflows and iterate on the process for continued refinement. • Develop strong collaborative relationships with key stakeholders across BeOne to identify opportunities for future process improvement initiatives.

🎯 Requirements

• Bachelor's Degree with 7+ years of IT, consulting, and/or project management experience required. • 7+ years in the pharmaceutical/bio-pharmaceutical industry with prior Regulatory Operations related experience preferred. • High Level of Competency Required: Veeva Vault Experience Preferred. • Microsoft Office and Adobe systems. • Project Management Tools: Microsoft Project or Smartsheet. • Regulatory Information Management (RIM) Systems (Veeva Vault, Liquent InSight, etc.). • Collaboration Tools (SharePoint, etc.). • Data Visualization Tools (PowerBI, etc.). • Familiarity with pharmaceutical development and Regulatory global submissions is a plus.

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness