BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Associate Director (AD) is responsible for providing post-production support for all Regulatory Technology & Information Management systems used within BeiGene, including creating and delivery of end-user system training. Develop strong partnership with internal and external stakeholders to support prioritization and implementation of user requested enhancements to the RIM platform, in coordination with key stakeholders within the business function, IT and external vendor(s). This includes activities related to business resource allocation, planning and budgeting (in partnership with IT), for key systems upgrade, monitoring, analysis of submission and registration information, and metrics reporting. This role is accountable for supporting Regulatory and registration data/ records integration and optimization efforts. Additionally, the AD will have management responsibility for RIM change control and stakeholder change management to ensure systems alignment with stakeholder/partner expectations, in compliance with evolving electronic data standards and submission of structured data. This role will have global responsibility for ensuring internal business processes and relevant regulatory guidelines &/or timelines are considered for system upgrade/changes, as well as allied process remediation. This role reporting to the Director, RIM is a critical member of the Regulatory Operations team, contributing to the vision, mission and strategy.
Essential Functions of the job:
Accountable and responsible for building and maintaining relationships within Regulatory Affairs and functional organizations including partnering with Quality (GxP Systems) and IT business partners to ensure effective communication and efficient management of regulatory technology and systems, as well as processes, as outlined below:
Lead and participate in business process and systems configuration workshops.
Manage business processes, operations, and updates for all Regulatory systems (post-production) supporting business needs of internal customers.
Responsible for providing business Technical Support in close collaboration with internal IT and external solution vendors.
Establish a robust global training framework for systems owned by Regulatory Operations, manage teams, and ensure on-going and timely training support for user community.
Provide support to QA/Compliance during system and business process audits.
Provide assistance and support to Regulatory Technology/RIM leads responsible for planning and building systems (spanning configuration and validation) to ensure successful production implementation, smooth transition for post-production support and system enhancements.
Outline and communicate to management resource requirements to support system enhancements, user training and routine global system support for users.
Implement optimal framework for managing (global) system change control requests in coordination with IT and QA organizations.
Primary conduit for all stakeholders for managing Regulatory Operations system related issues, requests, and expectations.
Ensure system support and training meets agreed Service Level Agreements (SLA).
Ensure system issues are quickly communicated and resolved.
Manage global teams focused on addressing system issues, new releases, and training.
Collaborate with internal stakeholders/customers to ensure alignment in strategy, communication, and delivery.
Strive for operational excellence and customer satisfaction.
Ensure compliance with internal SOPs, external standards (GxP) and audit requirements.
Supervisory Responsibilities:
Accountable and responsible for building and maintaining relationships within Regulatory Affairs and functional organizations including partnering with Quality (GxP Systems) and IT business partners to ensure effective communication and efficient management of regulatory technology and systems, as well as processes, as outlined below:
Lead and participate in business process and systems configuration workshops.
Manage business processes, operations, and updates for all Regulatory systems (post-production) supporting business needs of internal customers.
Responsible for providing business Technical Support in close collaboration with internal IT and external solution vendors.
Establish a robust global training framework for systems owned by Regulatory Operations, manage teams, and ensure on-going and timely training support for user community.
Provide support to QA/Compliance during system and business process audits.
Provide assistance and support to Regulatory Technology/RIM leads responsible for planning and building systems (spanning configuration and validation) to ensure successful production implementation, smooth transition for post-production support and system enhancements.
Outline and communicate to management resource requirements to support system enhancements, user training and routine global system support for users.
Implement optimal framework for managing (global) system change control requests in coordination with IT and QA organizations.
Primary conduit for all stakeholders for managing Regulatory Operations system related issues, requests, and expectations.
Ensure system support and training meets agreed Service Level Agreements (SLA).
Ensure system issues are quickly communicated and resolved.
Manage global teams focused on addressing system issues, new releases, and training.
Collaborate with internal stakeholders/customers to ensure alignment in strategy, communication, and delivery.
Strive for operational excellence and customer satisfaction.
Ensure compliance with internal SOPs, external standards (GxP) and audit requirements.
Education/Experience Required:
8+ years in the bio-pharmaceutical industry with prior Regulatory Operations and Information Management experience required. Bachelor's Degree a must. Master’s Degree in Information Sciences and/or Management desired.
Skills:
Microsoft Office and Adobe systems
Veeva Vault Admin Certification or Veeva Vault Admin minimum of 3 years
Regulatory Submissions Publishing experience preferred
Document management systems (Documentum, Veeva Vault, etc.)
Regulatory information management systems (Liquent InSight, CARA, Veeva Vault, etc.)
Collaboration Tools (SharePoint, etc.)
Labeling and eCTD Publishing Tools (InSight Publisher/Viewer)
Off-the-shelf and plug-in software (StartingPoint Templates, DXC Toolbox)
Other Qualifications:
Travel: <20%
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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