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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.
Job Title: Director, Global Regulatory Systems
The Global Regulatory Systems Director will lead the implementation and maintenance of Regulatory Information Management (RIM) Systems and other cutting-edge technology systems within the Global Regulatory Services & Operations (GRSO) team. The Systems Director will provide leadership and coordination of all technical advancement activities within the GRSO team and strategically develop the most effective solutions for their adoption.
The System Director maintains a visible presence with all business stakeholders, and all departments which impact the systems within the GRSO scope of management such as, Submission Document Management Systems (DMS) and Regulatory daily business applications (e.g. Publishing Tool, Regulatory Information Management System, eTMF and Safety Reporting tools). The Systems Director provides vision and maintains a broad perspective in responding to the system quality and maintenance needs of the Eisai user community reliant on the above-mentioned technologies.
Drive the effective implementation and maintenance of Regulatory Information Management (RIM) systems for GRSO.
Oversee capital spending budget for the global regulatory operations organization.
Effectively lead and manage a team spanning across multiple regions, providing leadership and mentorship within the unit to create a progressive learning environment.
Systems budget oversight to ensure all technology-based activities are accounted for on an annual basis Ensure all projects are managed effectively with the correct level of project management tools and skills assigned to allow each deliverable to be tracked and delivered according to leadership expectations.
Lead the development and finalization of contractual vendor agreements (MSA/SLA/SOW etc).
Oversight of continuous evaluations for systems performance and user adoption, with the intent to develop strategies to address any issues that may arise.
Drive compliance on an internal and external basis to ensure the correct processes and business direction for GRSO systems is in alignment.
Collaborate with Eisai Global ICT network to ensure all system activity is supported and visible.
Provide strategic technical oversight to department systems strategy planning.
Ensure alignment considerations with technical systems and internal business Process Management during project team forums, within the scope of GRSO ownership.
Maintain a current understanding of the industry expectations for system management and ensure that they are reflected in any technical business changes accordingly.
Support business functions (OBG/NBG/GRSO) by developing strategies that will allow them to have ‘Best of Breed’ technologies to support their product development activities.
Develop short and long-term strategies for business performance optimization.
Ensure compliance within the team’s activities in regard to documentation of the business process guidelines, SOPs, manuals, etc.
Ensures data integrity for all systems within the scope of GRSO is prioritized, allowing reliable live access to all related stakeholders.
Drive the alignment of Organizational Change Management (OCM) with all technical projects that will impact our business stakeholder community.
Supports Long Range Planning (LRP) and Capital Planning efforts in support of the Regulatory Affairs function.
Interacts with peers and stakeholders to drive efficient allocation of resources across related and partner functions.
Excellent communication skills Extensive knowledge of technical requirements in relation to all associated RIM systems.
Technical understanding of multiple systems and software such as Document Management Systems, Regulatory Tracking, the Microsoft Office suite, SharePoint and Publishing tools.
Strong leadership skills
Knowledge of Regulatory and Submissions processes for EU, US and ROW regions would be required.
Experienced in large or global scale system implementations.
Communication and stakeholder engagement skills are critical to the role.
Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build consensus.
Advanced presentation skills with the ability to present to all levels of the organization.
Experience in handling multiple tasks.
Experienced in supporting large, or global scale initiatives in related to RIM systems.
Knowledge of MS Office (Word, Excel, PowerPoint, Project), Adobe acrobat as well as being familiar with the use of multiple system applications.
Minimum of 10+ years of pharmaceutical regulatory experience, preferably in Regulatory Operations.
Minimum of 8 + years’ experience with document management systems, information management systems, or other related information technologies.
Involvement with Health Authority/Industry working groups or public speaking with a focus on eCTD, HL7 Standards, CDISC, SPL, IMPD, SEND, electronic gateways, or related areas.
Bachelor’s degree or equivalent in information technology, relational database management, systems administration, or related discipline.
Advanced Degree in business or information systems is preferred.
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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At Altria, we celebrate the power of diverse teams working together to shape our future. We are inspired to bring our best because our unique strengths are valued. We believe our personal success and progress should be guided by Our Cultural Aspiration, a new articulation of what w...e value and who we aspire to be, collectively. Our Cultural Aspiration respects and complements individual identity, embracing each other’s unique strengths, welcoming newcomers and developing the best, most inclusive and diverse teams. Over the next 10 years, we have the opportunity to make more progress on harm reduction than we have in the past 50 years. Join us as we work together to shape a better future for adult tobacco consumers, our employees, and our shareholders. Each Altria company is an equal opportunity employer.