At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.  If this is your profile, we want to hear from you.

The Project Manager, Change Management will be responsible for the post market activities of global biological pharmaceutical products regarding change control. This role involves strategic planning, regulatory compliance, project management, risk evaluation, and cross-functional collaboration to ensure the successful management and optimization of product portfolios.

Essential Functions

Strategic Planning:

• Manage strategic working meetings to evaluate product changes through the Quality Change Management process.
• Align life cycle strategies with overall business goals and market demand.
   

Regulatory Compliance:

• Liaison with global regulatory teams to ensure regulatory assessments and documents for product approvals, renewals, and variations are completed as required through the change control process.
• Communicate regulatory impact from proposed changes to the key stakeholders for impact to product supply and the associated filing strategies.
• Update the regulatory dashboard to ensure the requirements for each country are current and visible.

Cross-Functional Collaboration:

• Work closely with the Global Change Control Secretariate and the global change control committee to review the status of change controls and develop a supply and implementation timeline.
• Interface with Manufacturing, Quality, Regulatory, and Planning to ensure product supply and regulatory impact is communicated effectively.
• Facilitate communication and collaboration to ensure seamless change implementations.
• Lead cross-functional meetings to discuss and resolve life cycle management issues.
• Ability to work outside of normal business hours as required to collaborate with colleagues in other regions.

Project Management:

• Review strategy and status of Change Controls with key stakeholders.
• Monitor Change Control progress and ensure adherence to timelines.

Risk Management:

• Evaluate the timing and priority of changes so as not to impact supply and launch timing and communicate impact to the key stakeholders. Develop risk mitigation plans and implement corrective actions as needed.

Documentation:

• Prepare reports and presentations for internal and external stakeholders.

Continuous Improvement:

• Implement best practices and process improvements in the Change Control Process.
• Develop and manage KPI’s in relation to the Change Control process.

Requirements

Education:

 Bachelor’s degree in pharmacy, Life Sciences, or a related field. Advanced degree preferred.

Technical:

• Industry Experience: Minimum of 5 years in pharmaceutical life cycle management, change management or a related field.
• Project Management: Proven experience in managing complex projects within the pharmaceutical industry.
• Regulatory Knowledge: Strong understanding of pharmaceutical development and regulatory processes.
• Analytical Skills: Ability to analyze data to inform strategic decisions.
• Project Management: Excellent organizational and project management skills.
• Communication: Demonstrate superior communication and listening skills, working with all levels of organizational structure.
• Technical Proficiency: Familiarity with relevant software and tools used in change management.
• Global Experience: Background working with global entities is preferred.

Must Possess:

• Detail-Oriented: Meticulous attention to detail to ensure compliance and accuracy.
• Problem-Solver: Ability to identify and mitigate risks effectively.
• Team Player: Collaborative mindset to work seamlessly with various departments.
• Work Environment: The role is office based (hybrid) and may require occasional limited domestic and/or international travel. 

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Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status.  Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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