Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
M&D Strategy & Operations is a leader in aligning functions across M&D organizations in areas that impact quality management; process management; non-drug initiative management, including IT components, to support business strategy; business information reporting and analytics; resource management; and learning and development. As the Senior Information & Systems Strategy Manager, this position will be accountable for managing specific business support processes and oversight of complex information systems utilized within M&D through collaborative partnerships with cross-functional stakeholders in M&D and IS.
This position will be responsible for coordinating and managing the data model from implementation through to decommissioning for assigned clinical and/or operational system(s), including system integration processes for assigned system(s). The position will also be responsible for the intake and assessment of enhancement requests, developing of business design for solutions, overseeing change requests and establishing testing plans, as well as implementing configuration changes and execution of testing. This position will provide this support for the Clinical Trial Management System, and potentially other systems.
The position will work through collaborative partnerships with M&D Strategy & Operations operational strategists and functional stakeholders to advise on maintenance and updates of the data model, system features and integrations.
Essential Job Responsibilities:
* Advising in cross-functional collaborations on the maintenance, enhancements, upgrades, integrations, releases and decommissioning, as subject matter expert for system functionality, data model and security model, for assigned clinical and/or operational system(s). This includes responsibility for developing and implementing configuration changes.
* Leveraging drug development knowledge and cross-functional partnerships to anticipate changes needed to data structure and standards.
* Participating in continual improvement activities related to information and systems, incorporating industry best practices and vendor strategy and release plans into future iterations.
* Proactively identify impact of changes to business process and other impacted systems.
* Managing the user acceptance test process to ensure business requirements are appropriately tested and risks identified and mitigated
* Ensuring on-time implementation of assigned system(s) and new releases to end users, within budget constraints, in collaboration with IS and business functions
* Managing issues escalation for assigned system(s) through triaging mechanisms.
* Overseeing quality review process to ensure changes made in the data model are reflective of and consistent with agreed upon approach.
* Partnering with appropriate IS, quality and business functions to manage documentation and test strategies related to implementation of system enhancements.
* Developing and maintaining effective collaborations with key stakeholders and functions, as well as of relevant external stakeholders.
* Developing strategies for identifying and communicating critical factors in technical end user training for assigned system(s).
* Managing as a peer leader within the organization and actively participate to ensure success of the strategic objectives.
* Responsible for ensuring system compliance and management of the help desk.
* Responsible for budget and timelines associated with assigned system.
* May provide oversight and management of vendors or contractors.
* The position reports to the Director, Information & Systems Strategy.
* The position may oversee outsourced support staff.
* The position will work closely with other functions within M&D Strategy & Operations support any gaps or improvements needed in the data model for the system assigned.
* The position works cross-functionally with other Astellas groups to develop and implement excellence in business and clinical operations.
* Bachelor's degree required
* Minimum 8 years in the pharmaceutical industry and/or management consulting group focused on R&D or drug development, with minimum 3 years in the clinical operations setting.
* Previous experience in the development, deployment, and/or maintenance of clinical information systems (IVRS, CTMS, etc.)
* Demonstrated knowledge of the global drug development process to ensure cross-functional connections and operational data model are appropriately and effectively communicated across the organization.
* Experience in use of enterprise-wide pharmaceutical project management software solutions, including skills in critical path analysis.
* Excellent oral and written communication and presentation skills in English, with an ability to interact at all levels of personnel.
* Experience with establishing standards in support of clinical and business operations systems, especially as they impact and influence multiple departments and levels of management.
* Experience working cross-functionally and cross-culturally in support of business processes and/or systems, especially as they impact and influence multiple departments and levels of management.
* Strong and effective strategic thinker and problem solver with high degree of emotional intelligence, with the ability to both recognize and anticipate problems.
* Demonstrated ability to translate solutions into viable action plans at a global level that are effectively disseminated and implemented through cooperation of stakeholders.
* Demonstrated ability to effectively build business relationships and influence without authority as part of a matrix organization.
* Demonstrated ability to prioritize multiple projects efficiently.
* May require up to 10% international travel.
* Location for this position is Northbrook, IL, Leiden, Netherlands or Tokyo, Japan.
* Remote work possible.
* Minimum 3 years of people management experience, preferable in a highly matrixed, multicultural global setting.
* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled