Manager/Sr. Manager Information and System Strategy

Profile

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:

M&D Strategy and Operations (MDSO) is a leader in aligning functions across M&D organizations in areas which 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. The Information & Systems Strategy Manager will be accountable for leading specific business support processes and strategic oversight of complex information systems utilized within M&D through collaborative partnerships with cross-functional stakeholders in M&D and IS.

The position will be responsible for leading small to medium sized clinical systems projects. This could include managing medium-touch systems or managing a suite of smaller applications. The Information and Systems Strategy Manager will be the digital and content expert for one or more systems and/or reports and will have knowledge of other systems to assist the larger BIRA team.

Essential Job Responsibilities:

Accountable for:

Work with the leadership in the development of systems specific strategy and goals

For the enterprise planning and resource management application, Planisware, provide project management for assigned l system projects including responsibility for all phases of the project

Analyze and manage User Requirement and system change requests and coordinate user acceptance

Develop detailed project plans and manage project timelines and budget as appropriate

Ensure adequate resources are assigned in support of project/system including coordination of consultants

Accountable for on-time delivery within budget constraints, in collaboration with IS R&D Partners (RDP) and other internal key stakeholders as well as vendors.

Manage system upgrades, integrations, releases and decommissioning

Ensure deployment of system or new releases/upgrades including the timely delivery of project communications to end users and key stakeholders

Develop and execute a comprehensive communication and change management plan

Provide system support in partnership with RDP and other business functions and where appropriate:

Manage and solve user issues, communicate issues to vendor (incident and change management)

Interface with stakeholders to ensure study system builds result in interfaces being set up appropriately

Ensure the effective use of systems and compliance with internal and external requirements

Liaises with business process owner, systems trainer and help desk support to ensure system feedback loop

Support internal and external Astellas users within BIRA

May deliver end user training and train-the-trainer sessions as appropriate

Responsible for system vendor relationship management as appropriate

Quantitative Dimensions:

Responsible for ensuring system compliance and management of the help desk.

Responsible for budget and timelines associated with assigned system and associated initiatives.

May provide oversight and management of vendors or contractors working on a project, as applicable.

Organizational Context:

The position reports to the Director Information & Systems Strategy.

The position may oversee outsourced and/or junior support staff.

The position will work closely with other functions within MDSO support any gaps or improvements needed in the data model or reporting procedures for the system(s) assigned.

The position works cross-functionally with other Astellas groups to develop and implement excellence in business and clinical operations.

Requirements

Qualifications:

Required:

BA/BS required

Minimum 7 years in the pharmaceutical industry and/or management consulting group focused on R&D or clinical operations, with minimum 2 years in the drug development setting.

Previous experience in the development, deployment, and/or maintenance of clinical information systems (CTMS, etc.)

Experience in Software Development Life Cycles including requirements/specifications development and/or user acceptance testing for computer systems

Proficient project management and timeline management skills; ability to successfully manage a single project and associated tasks and manage risks

Basic presentation and communication skills, negotiation and follow-up skills

Ability to interact and network effectively with internal customers and external vendors

Dedication to customer service, and experience delivering on customer needs

Basic understanding of available business and clinical databases within Astellas

Knowledge of the Pharma Development business process and conduct of Clinical Trials

Forward thinking and creative solution development

Attention to detail

Works well individually and demonstrates good people/team skills

Training in Regulatory and System Compliance

Applied GXP experience in pharmaceutical or biotechnology industry with clinical drug development experience

Knowledge of ICH and GCP required

Proficient computer skills across multiple applications

Fluency in written and spoken English

Position may require domestic and international travel

Preferred:

Experience with the Planisware Enterprise solution, minimum one year

Minimum 1 years of people management experience, preferable in a highly matrixed, multicultural global setting.

Benefits:

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

#LI-SS

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Type

Full-time

Location

IL, Northbrook

Category

Medical & Development

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/