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Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Company's greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
The Senior Director, Data Management Services will be responsible for overseeing all Neurology Business Group (NBG) Data Management (DM) activities within the US and UK locations and must be fully versed in all aspects of drug development - data management. The incumbent must be an experienced manager with demonstrable leadership skills (communication and interpersonal) attributable to their most recent 6 to 8 years of work history, including direct hands-on NDA submission experience across multiple therapeutic areas, and effective management of CROs. This person possess solid understanding of clinical trials and outcomes, therapeutic area expertise, and protocol knowledge. Must be capable of leading cross-functional initiatives and effective in preparing for and navigating through health authority inspections in both regions. In-depth understanding of GCP practices, DMP, eCRF design of EDCs/IRTs, SOP development and process improvement are required.
Develops strategic approach for IAM and other programs under the Senior Director's responsibility;
Develops mission statement, objectives, stakeholder engagement plan and strategic plan for programs;
Leads program design and management working directly with customers and business owners on the integration of requirements; for the IAM program, this includes provisioning, de-provisioning and all aspects of user lifecycle;
Develops methods and framework for selecting the best tools and partners for Eisai to fulfill the needs of programs under Senior Director's responsibility;
Regularly reports to management and leadership on status of program, risks, accomplishments, schedule, budget;
Creates partnerships with Eisai team, stakeholders, vendors and partners to develop and manage programs;
Leads the team in maintaining and assessing operational requirements and service issues for improvement opportunities;
Develops enterprise-wide standards; develops identity and access management policy and SOPs;
Consults with business units when implementing user roles for new systems;
Leads the team in creating and maintaining the architecture for IAM systems;
Performs additional duties as assigned.
BS/BA and/or MS/MA in relevant field required.
10-12 years experience in Data Management methods and processes in pharmaceutical industry setting required.
Must have at least 6 years of managerial/leadership experience.
Proficient in communicating and clearly conveying ideas across varying populations.
Adept at influencing others.
Able to think clearly on one's feet, anticipating discussion direction in order to ensure desired results.
Must be comfortable in dealing with ambiguity.
Practical knowledge / understanding of Data Operations.
Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai's policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer - Minority / Female / Disability / Vet
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