Description ABOUT US: Infosys is a global leader in technology services and consulting. We enable clients in more than 50 countries to create and execute strategies for their digital transformation. From engineering to application development, knowledge management and business process management, we help our clients find the right problems to solve, and to solve these effectively. Our team of 199,000+ innovators, across the globe, is differentiated by the imagination, knowledge and experience, across industries and technologies, that we bring to every project we undertake. RESPONSIBILITIES Infosys Consulting is looking for talented and highly motivated consultants to join our Life Sciences consulting practice. As a Principal, you will work on strategic programs in the regulatory affairs helping clients in biopharmaceutical, medical devices and drug distribution sector develop strategic business capabilities while further deepening your knowledge in in this area.
Lead strategic business transformation programs, manage program planning, execution and reporting; responsible for program resources, deliverables, quality, stakeholder communication, client buy-in, program risks, mitigations and budgets leading to successful program delivery and client delight
Engage with key stakeholders; manage day-to-day interactions with client teams
Conduct interviews/workshops/walkthroughs with subject matter experts and process owners to gather information for analysis, recommendations and for preparation of project deliverables
Develop solutions that enable adoption of digital capabilities for Life Sciences organizations. Participate in analyst meetings, industry speaking engagements, publish white papers/view points in leading industry journals.
Participate in practice development activities; coach junior consultants; participate in consultant training processes.
Ability to travel 4 days a week to multiple client locations
BASIC QUALIFICATIONS Demonstrates proven success in roles and thorough abilities in one or more of the following areas:
Understanding of key Pharmaceutical R&D processes and technologies
Familiarity with industry-standards such as ICH, IDMP, XEVMPD.
Subject matter expertise in areas such as document management, requirements management, submission planning and tracking, submission publishing, and registration and commitment tracking.
Knowledge of publishing software and tools used throughout the Pharmaceutical industry
Working knowledge of Pharmaceutical Regulatory Submission requirements as defined by International Conference of Harmonization and Global Health Authority Guidelines
International regulatory understanding and experience in handling business process excellence
7-9 years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
Bachelor s degree, preferably in pharmaceutical sciences or related field
Successful track record using Lean/Agile approaches to build digital solutions in a multi-disciplinary, multi-vendor corporate setting
Experience in translating business objectives to system requirements
Experienced in leading strategic and tactical discussions with Senior Director and Director levels
Industry experience working directly at pharmaceutical, medical devices or pharmaceutical distributor organization is a plus
MBA and/or Advanced degree (MS, MPH, and/or PhD) is preferred