The Associate Director Information Technology will be reporting to the Director, R&D IT, Clinical/Safety/Regulatory, and will serve as focal point for, and develop strong client relationships with Drug Safety and Risk Management (DSRM) focusing on optimizing Adverse Event and submission processes.

Job Description:

The Associate Director Information Technology will perform all or some of the following Job description:

• Understand the processes, plans, objectives, drivers, and issues related to this business area

• Develop, communicate, and execute on a business-aligned IT strategy that will contribute to the success of Company Development efforts

• Develop business cases, secure approval & resources required to pursue the development of new capabilities & investments, manage the development of requirement specifications related to these, and charter & guide the efforts of matrixed project teams in their implementation

• Direct the proper execution of IT projects and services; ensure that the appropriate delivery-side & architecture resources are available to support & sustain projects; negotiate priorities and support requirements with shared services & infrastructure IT

• Work with Drug Safety leaders and MDs to ensure that IT has a role within all major strategic change initiatives and that the value of IT consultancy is recognized by DSRM

• Act as a change agent to align the IT portfolio with business strategy, the IT strategic plan and corporate IT architecture, and is responsible for communications between the business area and other IT

• Represent the business requirements of DSRM within the corporate IT organization

• Responsible for assessing & communicating impacts of strategic IT initiatives on behalf of DSRM

• Participate to groups and perform some technology intelligence to ensure the needs are met according to industry standards

• Build a strong organization in order to fulfill those duties

• Complete the due diligence regarding the Adverse Event reporting Systems and bring consensus on a decision for DSRM

• Develop the strategy to enhance the epidemiology activity within DSRM

• Facilitate access to Clinical Trial data for develop the signal detection capability.

• 10+ years' experience working as an IT professional, with at least 5+ years' experience in an IT leadership or Drug Safety role
• 5+ years' experience in program management and/or business analysis
• 5+ years' experience in a biotech/pharma environment and proficient with Drug Safety process flow, Adverse Event, Epidemiology, Signal detection and associated technology platforms
• Keenly developed business partnering & collaboration skills, adept at establishing & sustaining effective working relationships, both within & between departments
• Demonstrated successful management of projects, including scope, financial, and schedule goals
• Experience working with solutions delivery teams such as corporate IT infrastructure/architecture, applications development & integration, & support in the implementation and maintenance of scientific computing platforms & applications
• Ability to operate effectively in a matrix environment; team player
• Familiarity with supporting applications such as AERS, ARGUS, ClinTrace
• Experience with IT system environments subject to regulatory controls (GxP, 21 CFR Part 11)
• Ideally - experience with Japan Regulation
• Knowledge of Argus
• Knowledge of analytics tools (WebSDM, IReview, JReview)
• Knowledge of the submission standards and regulation in US and International.

• BA or BS in relevant life sciences.
   

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