Manager - R&D / Medical Applications

Company Name:
The Manager - R&D / Medical Applications leads development and day-to-day production support for new and existing global solutions supporting Global Medical & Regulatory Affairs (GMRA) , Group Quality and the R&D departments. Primary application areas include Clintrace, MedDRA, Trackwise and Documentum. Manages the planning and implementation of complete business solutions (technology, applications, processes and training) in accordance with regulatory requirements. Primary support person for the company's global Drug Safety systems. Partners with key business counterparts to rationalize business processes, and designs innovative solutions supporting these processes. Participates and advises customers in key technology decisions (e.g. selection of external partners, evaluation of insourcing and outsourcing alternatives, establishing business plans/priorities, tool selection). Oversees the completion of initiation, requirements, design, build, test, implementation, and support of solutions.


Deliver projects with high quality, within the agreed upon budgetary and time constraints in accordance with business expectations.
Lead strategic and operational planning processes as a member of the IT Leadership team. Lead the development and control of 3-year strategic and annual operating and capital budgets and develop business case justifications for initiatives aligned to business operations and strategy.
Serve as the ?go to? IT person for GMRA and Quality Application areas globally. Monitors and ensures a high level of customer satisfaction regarding activities that are executed not only by the R&D Medical Applications team but also by all other IT functions.
Ensure the delivery of support that is consistent with end user expectations and service level agreements. Monitor and report operational service level agreements across applications and technical operations teams. Review log files, system performance and system availability performance levels to plan capacity, tune performance, and schedule system patches, upgrades, and maintenance. Drive the development of approach for 1st, 2nd and 3rd level support services defining service level agreements. Implementation of help desk procedures and FAQs.
Partner and align IT with business objectives by establishing working relationships at individual and department levels with all business partners. Responsible for educating business colleagues on how technology can be leveraged for business value and growth. Identify practical yet innovative solutions to meet business needs. Facilitate the definition of business and system requirements for new technology initiatives.
Administration of project management processes and tools including issues management, budget management, project planning and tracking, risk and expectations management. Provide regular written and verbal project communications/updates of status and issues. Coordinate activities across vendor, end user and internal IT resources to achieve deliverables as defined in project plans.
Accountable for internal and external resource planning, allocation, and supervision. Manage day-to-day activities of 2-5 internal and/or external team members. Review and evaluate direct reports and peers and prepare annual performance reviews. Work with team members to develop development plans and sets goals and objectives.
Coordinate software and hardware purchases and legal agreements through technical operations and legal team, as appropriate.
Manage external relationships with vendors. Lead and manage IT vendor evaluations, selections, and negotiations. Accountable for escalation and managing of issues with vendors.
Identify resource requirements and build technical competencies within team or as required externally to support application areas.
As a member of the ITS Leadership team participate in strategies and decisions for resource planning, portfolio planning, supervision and team development.
Develop best practices which can be leveraged across ITS teams with an objective to streamline work processes.
Manage the construction and/or updates to system documentation in accordance with regulatory and/or departmental requirements.


o Seasoned IT leader with 7 years of experience working in a product based company. 3-5 years project management and/or managerial experience.
o 3-5 years of experience in supporting FDA regulated R&D applications
o Solid hands on configuration/development experience with Clintrace. The knowledge of Argus or ArisG is a plus. .Net development experience is also a plus.

o Proven project management experience in facilitating the definition of business requirements and designing and implementing solutions, including processes and managing change.
o Pharmaceutical and/or healthcare applications experience.
o Experience working with many and varied third party vendors.
o Demonstrated ability to apply IT in solving business problems.
o A track record of success in managing IT operating and capital budgets.
o In-depth knowledge of structured systems development methodologies, information technology and the management of day-to-day operations.
o Bachelor?s Degree in Computer Sciences, Engineering or equivalent work experience.

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