研发与监管系统负责人

Mylan Inc.Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities.
Every day, we rise to the challenge to make a difference and here’s how the R&D and Regulatory Systems Lead will make an impact:
R&D and Regulatory Systems Lead position works with Regulatory Affairs and other R&D functions to understand technology needs, ensure global processes and systems are compliant and representative of cross functional needs. The successful candidate will demonstrate strong Veeva RIM architecture and development experience including hands on experience of Registrations & Submissions Vault configurations, integrations and data migrations. Business process knowledge is required for requirements elicitation as well as good communication and project management experience to lead technical implementations and take on system ownership.
Key responsibilities for this role include:

• Provide strong working knowledge of the digital capabilities used to support global R&D business processes

• Monitor emerging global health authority requirements to assess system impact including developing and implementing requirements to ensure compliance

• Collaborate with key business users to identify business needs and translate to requirements. Translate user requirements into technical requirements and implement solutions to meet requirements according to industry best practices

• Provide analysis techniques including functional requirements gathering, process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis

• Provide Veeva RIM Vault administration and development expertise including all facets of package software, application implementation and integrate systems using Vault API calls

• Lead administration, enhancements, fixes, configurations of RIM Vaults and migrate new code fixes in a regular deployment schedule

• Leads technical design for assigned projects and enhance integrations between systems

• Designs, architects, and leads development of complex applications

• Successfully manage assigned projects to implementation ensuring projects successfully deliver in scope, on schedule and within budget.

• Work with teams globally for end-to-end implementation of various R&D solutions and ensure compliance with regulations by FDA, EMA and other health agencies.

• Drive compliance with IT Quality processes and Viatris SDLC processes, including IT change management and quality/testing procedures.

• Collaborate with solutions lead and business partners to ensure technologies are meeting business requirements

• Support vendor relationships for assigned R&D systems, ensuring that system issues are promptly escalated

The minimum qualifications for this role are:

• Bachelor's degree in science, IT, or a relatable field. Advanced degrees are a plus.

• Veeva RIM Vault certification preferred.

• 10 years’ of Regulatory business process knowledge and strong hands-on technical experiences configuring, migrating and integrating Veeva RIM Vaults and other R&D solutions required.

• 10 years’ hands on experience with software design and development, system integrations, analytics report builds required.

• Prior experience in the pharmaceutical industry and a solid understanding of R&D & Regulatory business processes.

• Experience with validated GxP environments, including Implementation, documentation, and change management is necessary.

• Hands on experience implementing, configuring, migrating and integrating Veeva Vault RIM platform including Registrations, Submissions & Archive Vaults (Required). Veeva certification desired.

• Broad technical knowledge, including hands on experience designing and implementing system integrations as well as working with migrations and SaaS in a regulated environment.

• Hands on experience designing and building solutions with Java, python, creating AI agents and working with analytics tools including building Power BI reports

• Proven track record of defining technology strategy aligned with business objectives

• Previous experience as IT system owner supporting R&D

• Experience in business processes for regulatory submission planning and tracking, registration management, commitment management and content management

• Knowledge of GCP, EMA + FDA regulations and other regulatory compliance standards

• Experience with project management methodologies such as Agile, Waterfall, and Hybrid approaches

• Strong analysis and project management skills as well as attention to detail

• Ability to challenge requirements with key stakeholders to ensure requirements are detailed and properly defined

• Ability to solve highly complex enterprise-wide technical challenges

• Ability to operate in a dynamic challenging environment and manage multiple activities, priorities, and deadlines.

• Excellent verbal and written communication skills

• Works well in and appreciates the value of a global diverse work environment.

• Is able to see the larger picture and able to identify and successfully communicate key issues in complex situations.

• This role has remote flexibility and will work with Global business in IT teams in US EST, EU and IST time zones.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 USD.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
Originally posted on Himalayas