Role and Responsibilities;
The successful candidate will work closely with IT management and the clients to identify and specify business requirements and processes in diverse development platforms, computing environments (e.g., host based, distributed systems, client server), software, hardware, technologies and tools.
• Work with a diverse business community to document as-is and to-be business processes;
• Document clear and testable requirements which describe a system to be implemented;
• Collaborate in the creation, review and approval of validation documents
• Recommend business process and system changes to improve efficiency and business outcomes;
• Participate as a key member of implementation projects, which may include requirements gathering, application design, software configuration, testing, validation and end-user knowledge transfer;
• Help facilitate clear communication between business stakeholders and IT technical teams;
• Provide industry best practices and support the change management process.
• Manages day-to-day client interaction and expectations for multiple or large-scale projects. Continually seeks and capitalize upon opportunities to increase customer satisfaction and deepen client relationships;
• Possess a knowledge base of the business, organization and objectives;
• Maintains awareness of new and emerging technologies and the potential application for the business.
Education and Qualifications
• Degree in a related field
• Experience in a Pharmaceutical, Biotech, Medical Devices or Research environment preferred
• 6 years industry experience
Knowledge and Skills
Demonstrated ability to interpret and document an extensive variety of business and technical processes.
Requires an in-depth knowledge of the system development life cycle.
A demonstrated ability in creation of requirements, design documents and test scripts
Must be competent to work at the highest technical level of all phases of system design and implementation.
Ability to communicate at all levels with clarity and precision both written and verbally together with strong presentation skills.
Excellent oral and written communication skills are required.
Ability to anticipate client needs and propose alternative business solutions.
Excellent interpersonal skills.
Must show strong judgment and time management skills.
Strong Customer Service Focus.
Ability to work alone or as part of a team.
Knowledge of GMP essential
Knowledge 21 CFR Part 11 and Annex 11