Senior Principal Research and Development Life SciencesInfosys Consulting is looking for talented and highly motivated consultants to join our Life Sciences consulting practice specializing in Regulatory Sub Practice of Larger Life Sciences Consulting.RESPONSIBILITIES - In depth knowledge of Pharma Regulatory Operations and Regulatory IT Systems aligned to core Functional and Technical competencies
- Expert in Regulatory area with ability to drive futuristic IT solutions and experience in client facing and agency thought leadership.
- Understanding and knowledge of processes related to health authority submissions content authoring labeling lifecycle management of CMC regulatory intelligence and country-specific regulatory requirements keenly aware of industry trends needs and business requirements expected from clients
- Able to strategize and advise on the product roadmap and should work closely with the client in delivering solutions.
- An empathic people manager responsible to mentor and guide a team for progressive outcomes
- Lead strategic 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.
- Lead in sales pursuits in collaboration with larger Infosys teams; lead the proposal development process; proposal content creation and client presentations.
- Develop solutions that enable adoption of digital capabilities for Life Sciences organizations. Participate in analyst meetings industry speaking engagements publish white papers/ viewpoints 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 - The candidate should have a rare blend of industry domain process technical and consulting skills. Consulting skills should entail client relationship management effective executive communication critical thinking in a consultative approach with our clients. Additional skills that are highly desirable include value realization process re-engineering design thinking and agile delivery experienced
- Should have a masters degree in Life Science Medical or Related discipline. Masters in business administration would be an added advantage.
- Minimum 12-15 years experience in Regulatory Strategy Operations and Intelligence across Biopharma and Medical Devices.
- Deep understanding of RIM systems i.e. Veeva Vault LIQUENT and publishing tools.
- Knowledge of regulatory IT systems landscape and implementation experience inclusive of integration and Migration aspects
- Forward thinking skills in reshaping patient support and market access agenda as it evolves.
- Thought leadership and critical problem solving skills
- Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time
For candidates based out of NY NJ states estimated annual compensation will be $157500 to $192500Along with competitive pay as a full-time Infosys employee you are also eligible for the following benefits :- Medical/Dental/Vision/Life Insurance Long-term/Short-term Disability Health and Dependent Care Reimbursement Accounts Insurance (Accident Critical Illness Hospital Indemnity Legal) 401(k) plan and contributions dependent on salary level Paid holidays plus Paid Time OffAbout UsInfosys Consulting is the global management and technology consulting practice of Infosys a global leader in technology services and consulting. We combine the power of time-tested methodologies people-driven innovation and disruptive technology to enable leaders of the worlds top brands pursue a path of smart transformation. Together with our clients internal and external partners we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants:
Ability to design and implement end-to-end solutions at scale
A flat organization structure with direct access to our senior-most leaders
An entrepreneurial environment full of bright highly motivated consultants
Opportunities for motivated consultants to impact local communities
The ability to design your career and drive your professional learning and development
A truly global culture
Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills expertise and ideas from our innovation ecosystem.
Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy childbirth or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.