IT Platform Lead

At VIATRIS™, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

- Access – Providing high quality trusted medicines regardless of geography or circumstance.
- Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership – Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the Platform Lead R&D and Regulatory Affairs role will make an impact:

This Global people manager role will be responsible for leading activities from planning to closure for multiple global R&D IT projects, including establishing outcomes and measuring successful delivery against those outcomes.

LOCATION

Bangalore preferred or Hyderabad

KEY RESPONSIBILITIES

Works with teams globally for end-to-end implementation of various GxP R&D and Regulatory Affairs systems to ensure compliance with regulations by FDA, EMA and other health agencies

Leads the creation of project management plans that clearly define the project scope, assumptions, risks and overall project approach including project resource needs, high level timelines, and project communications.

Develops and administers project budgets, schedules, and performance standards.

Coordinates and responds to requests for changes from original scope.

Assigns duties, responsibilities and scope of authority to project personnel. Directs and coordinates activities of project personnel to ensure the project progresses in scope, on schedule and within budget.

Drives compliance with the IT Quality processes and Viatris SDLC process, including the IT change management and quality/testing process.

Analyzing scope of work to define the project goals, prioritize the project activities as per the project plan and manage resources.

Responsible for ensuring completeness of Statement of Work to mitigate future conflicts by binding scope and foreseeing the project needs; keeping budget, timelines and scope of work in consideration

Enforcing Systems Development Life Cycle standards and required regulations to projects.

Collaborates with key users of various functions of R&D and Regulatory Affairs across geographies.

Drive the project delivery to ensure conformance to predetermined schedule, budgets & milestones of the projects.

Communicates project status to project steering committee and other stakeholders as appropriate. Manages project issues/risks in a timely manner and appropriately escalating when necessary.

Provides leadership and motivation to direct reports and project management resources. Mentors, coaches, and trains others.

Assist other project managers on the team by providing technical expertise to architect solutions, ensure secure IT solutions are implemented, troubleshoot issues, and adhere to Viatris best practices and SOPs.

Liaise with business partners and technical staff at the Global Infrastructure Development Center on behalf of the R&D IT application group during daytimes hours in IST time zone.

Partner with run support team, directing and educating them as needed to improve the support of electronic systems used to support Viatris regulatory and scientific affairs business units.

Discover and lead novel ways of getting solutions put into place by leveraging expertise across the organization.

Responsible for providing system ownership and support for R&D and Regulatory Affairs systems which includes partnering with IT support teams to maintain deployed solutions

Guide other system owners on maintenance processes and improvements as well as troubleshooting and resolving issues together with support teams.

Collaborate with key global business users to elicit and refine requirements for various functions of R&D and Regulatory Affairs) as well as collaborate with solutions lead to ensure proposed technologies are meeting requirements

Escalate issues and concerns to leadership and proactively work together on timely solutions.

Veeva RIM Registrations technical subject matter expert leading system integrations, administration, configurations, design, and development including all facets of application implementation

Other duties as assigned

QUALIFICATIONS

KNOWLEDGE

Must possess extensive knowledge of project management concepts, practices and procedures as they relate to the delivering IT project.

Must understand and apply all of the Project Management Body of Knowledge Competencies.

Prior experience of working with R&D and Regulatory Affairs is be preferred.

Knowledge of Veeva RIM Registrations and Submissions Vaults is preferred.

SKILLS AND ABILITIES

Achieves high results through people.

Demonstrates strong oral and written communication skills.

Works well in and appreciates the value of a globally diverse management, employee, and contractor environment.

Performs well under pressure. Shows diplomacy, tact and good judgment when conflict arises.

Proactively plans for managing and mitigating project risks.

Is able to see the larger picture, able to identify patterns or connections between situations not obviously connected; able to identify key issues in complex situations.

Knows when and when not to act authoritatively in order to obtain maximum performance from colleagues.

Possesses a clear vision of project direction/outcome and ability to communicate this vision; instils a sense of project ownership.

Navigates corporate situations and diffuses potentially volatile situations; is able to tap into the power structures of organizations.

SUPERVISION

Position functions autonomously and has direct reports. Receives abstract assignments. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities encompass completing or delegating the following processes including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION/EXPERIENCE

Minimum of a Bachelor's degree (or equivalent) and 8 years relevant experience with Master’s Degree is preferred. However, a combination of experience and/or education will be taken into consideration.

LICENSES/CERTIFICATIONS

Veeva certification preferred. PMP certification is preferred.

LANGUAGE SKILLS

Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.

MATHEMATICAL SKILLS

Has an understanding of earned value metrics and how to use them effectively on projects.

REASONING ABILITY

Ability to solve complex problems with a variety of variables through nonstandard solutions that require in-depth analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve complex problems.