Manager, IT, R&D

Manager, IT, R&D & Regulatory Systems page is loaded

Manager, IT, R&D & Regulatory SystemsSolicitar locations Northern Cross, Dublin, Ireland United Kingdom Remote Office time type Tiempo completo posted on Publicado hace 11 días job requisition id R5660055 McDermott Laboratories Limited

En VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.

Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.

Lo hacemos a través de:

Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;

Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;

Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

R&D and Regulatory Systems Manager position works with business partners in CMC, Regulatory Affairs, Medical Devices and other R&D functions to understand technology needs, ensure global processes and systems are compliant and representative of cross functional business needs. The successful candidate will demonstrate strong global CMC and Regulatory domain expertise, have hands on business analysis & IT project management experience including detailed requirements elicitation. Successful candidate will bring knowledge of configuring, integrating, and migrating Veeva RIM Registrations and Submissions Vaults.

Every day, we rise to the challenge to make a difference and here's how the Manager, IT, R&D & Regulatory Systems role will make an impact:

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

• Understand CMC, medical devices and regulatory processes and identify health authority trends and policies that could impact current systems.

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

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

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

• Successfully manage IT projects for R&D to implementation by coordinating activities of project personnel to ensure the project successfully delivers in scope, on schedule and within budget.

• Support project execution tasks to configure, integrate and migrate Veeva RIM Registrations and Submissions Vaults.

• Work with teams globally for end-to-end implementation of various R&D systems 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 the vendor relationship for assigned R&D systems, ensuring that system issues are promptly communicated.

About Your Skills & Experience

For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

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

• Prior experience in the pharmaceutical industry and a strong understanding of global R&D CMC, Medical Devices & Regulatory Affairs business processes.

• Experience with validated GxP environments, including Implementation, documentation, and Change Management is necessary.

• Hands on experience implementing, configuring and integrating Veeva Vault RIM platform including Registration, Submissions & Archive Vaults. Veeva certification desired.

• Broad technical knowledge, including experience with SaaS in a regulated environment.

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

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

• 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.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Why Viatris?

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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

En Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.

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