Associate Director Process & Procedures Systems

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Job description

The Associate Director, Systems Management is responsible for the strategic oversight and day-to-day management of systems that support the delivery of regulated documentation to business stakeholders. This role involves maintaining the electronic Document Management System (EDMS), acting as the Business Process Owner (BPO) for the EDMS workstream and workflows for Global Development, and collaborating with various departments to ensure the smooth operation and continuous improvement of these systems. This role will lead the identification of EDMS data for reporting, analysis, and integration with other P&P software.

In this role, a typical day might include:

Strategic System Oversight and Day-to-Day Management:

• Provide strategic direction and oversight for systems that support the delivery of regulated documentation.
• Monitor system performance and address any issues that arise to minimize downtime and ensure continuous availability.

Electronic Document Management System (EDMS) Maintenance:

• Oversee the maintenance and strategic enhancement of the EDMS, including managing workflows, folder structures, and other related components.
• Ensure the EDMS is up-to-date and compliant with regulatory requirements.

Business Process Owner (BPO) for EDMS:

• Act as the Business Process Owner for the EDMS workstream and workflows for Global Development.
• Develop and implement best practices for EDMS usage and ensure adherence to these practices across the organization.

Metrics and Reporting:

• Lead the preparation and oversight of P&P Veeva quality metrics.
• Create and monitor Veeva cycle time metrics for reporting and potential opportunities for improvement.

Support Veeva Training:

• Provide oversight of Veeva training to ensure P&P colleagues and vendors have the appropriate access and capabilities.
• Ensure training content is current.

Support for Validation Deliverables:

• Collaborate with Global Development IT and other key stakeholders to support the review and approval of validation deliverables.
• Ensure all validation activities are completed in accordance with regulatory requirements and company policies.

System Release Notes Analysis:

• Analyze quarterly system release notes to identify potential system configuration changes.
• Communicate relevant changes to the team and implement necessary updates to maintain system efficiency and compliance.

Collaboration with Other Departments:

• Work closely with Integrated Operations (IOPs), BioAnalytical Systems (BAS), and Drug Safety and Pharmacovigilance (DSP) to ensure the EDMS meets the needs of all stakeholders.
• Facilitate cross-departmental communication and collaboration to enhance system functionality and user experience.

Future System Uses:

• Analyze, propose, and strategize on future system uses, such as Process Navigator.
• Identify opportunities for system enhancements and lead initiatives to implement these improvements.
• Collaborate with other P&P colleagues to explore integrating data with project planning software and the resource tracker.

Leadership in Committees and Meetings:

• Lead Operating and Governance Committees and other key system meetings.
• Provide updates on system performance, upcoming changes, and strategic initiatives to senior management and other stakeholders.

Continuous Improvement:

• Identify and implement opportunities for technology innovation, improvement, and integration.
• Collaborate with internal P&P colleagues and other key stakeholders to strategize and propose system enhancements.
• Facilitate requirements meetings, define system requirements for enhancements or system configuration changes in collaboration with Validation representatives.
• Collaborate with the P&P leadership team to prioritize proposed system changes.
• Develop use cases in collaboration with GD, BAS, and DSP functional representatives.
• Modify system validation deliverables, obtain input from stakeholders, and finalize documents (e.g., URS, Config Spec) as needed to support system change controls.
• Analyze system issues and propose mitigation strategies.

Stakeholder Collaboration:

• Work closely with business leaders to understand their technology needs.
• Liaise with key internal and functional stakeholders to support procedural documentation needs, ensuring alignment with document hierarchy and regulations, and responsible for periodic reviews.
• Liaise with P&P and functional stakeholders across GD to appropriately support and drive decisions related to P&P projects, making necessary assessments based on project prioritization and potential risk.
• Collaborate with IOPS to align, where possible, on system configuration between IOPS EDMS and GD EDMS.
• Communicate technology plans and progress to stakeholders.

Risk Management:

• Identify and mitigate risks associated with technology projects.
• Ensure compliance with relevant regulations and standards.

This role might be for you if have:

• In depth knowledge of GCP/GxP and regulatory requirements
• Strong leadership with demonstrated ability to interact with all levels of the organization
• Demonstrated success in project management, stakeholder management, collaboration and negotiation of complex situations
• Self-motivated with the ability to work effectively in a dynamic environment
• Demonstrates skills in problem solving, working independently and in a team environment
• Ability to effectively manage multiple priorities with a sense of urgency
• Ability to thrive in fast-paced, deadline-driven environment
• Excellent written and verbal communication skills
• Demonstrates strong influencing and negotiating skills with the ability to communicate effectively at all levels of the organization
• Ability to multi-task and manage conflicting/changing priorities

To be considered for this opportunity, we require a Master's degree and 8 years of experience or 10 years of experience with Bachelors within the life science industry. We expect you to display the following competencies: Leadership, Stakeholder Management, Project Management, Process Management, Strategic Thinking, Critical Thinking & Problem Solving, Integrity and Trust, Negotiating, Ability to manage ambiguity. We also require you to be onsite three days a week at a minimum.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$151,800.00 - $247,800.00

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