Assistant Manager, GRA Business Process


Job Location:

Dublin - Ireland

Monthly Salary: Not Disclosed
Posted on: 21 hours ago
Vacancies: 1 Vacancy

Job Summary

McDermott Laboratories Limited

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 lifes 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.

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

The Assistant Manager GRA Business Process will support the Global Regulatory Affairs (GRA) Business Processes team in the development optimization and implementation of business processes. The role is responsible for developing clear compliant and user-friendly documentation such as Standard Operating Procedures (SOPs) Work Instructions (WIs) Job Aids (JAs) and Quick Reference Guides (QRGs) that translate complex regulatory processes into practical easy to follow guidance and enable consistent execution of regulatory processes across global teams.

This position works closely with GRA Compliance Learning and Development (L&D) Metrics teams and subject matter experts (SMEs) to ensure all documentation aligns with regulatory requirements internal quality standards and operational performance goals.

Every day we rise to the challenge to make a difference and heres how the Assistant Manager GRA Business Process role will make an impact:

  • Develop high quality SOPs WIs JAs and QRGs that support global regulatory processes ensuring clarity accuracy and alignment with controlled document standards.

  • Draft new business processes based on SME input process maps regulatory requirements internal references and system workflows translating complex concepts into clear and actionable guidance.

  • Participate in process design meetings system demonstrations and workflow reviews to understand end to end processes and accurately reflect them in documentation.

  • Incorporate diagrams screenshots process flows and other visual elements to enhance usability and comprehension across global audiences.

  • Partner with GRA Compliance L&D Metrics teams and SMEs to support communications and training relating to Regulatory process development and improvement.

  • Coordinate review and approval process in D2 for developed Regulatory business processes.

  • Maintain documentation repositories version control and update cycles in alignment with GRA governance models and continuous improvement initiatives.

  • Identify documentation gaps redundancies and opportunities for simplification using data insights and stakeholder feedback.

  • Compile ideas from stakeholders to identify opportunities for process and/or systems improvement.

  • Support development and monitoring of regulatory process adherence oversight.

  • Ensure all documentation is audit ready traceable accessible and compliant with internal quality standards and global regulatory expectations.

  • Conduct periodic reviews of Regulatory business processes to keep content current with evolving systems regulations and business processes.

  • Support maintenance of Regulatory business process webpages.

About Your Skills & Experience

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

  • Experience in Regulatory Affairs function within Pharmaceutical Biotech Medical Devices or other highly regulated industries required.

  • Proven ability to draft SOPs WIs JAs and QRGs with strong skills in process documentation workflow analysis and information design.

  • Experience using electronic document routing and workflow platforms to support controlled document processes.

  • Excellent writing editing and communication skills with a focus on clarity compliance and usability for global audiences.

  • Proficiency with documentation tools such as SharePoint SnagIt Visio Documentum or similar with the ability to manage multiple projects in a fast paced global environment.

  • Previous experience in process design and project management preferred.

  • Strong knowledge of departmental and organizational policies procedures and systems.

  • Basic flowcharting skills (e.g. Visio) preferred.

At Viatris we are dedicated to building a truly diverse inclusive and authentic workplace so if youre excited about this role but your past experience doesnt fully align with every requirement we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits at 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. Some of our benefits include the following on top of a competitive salary:

  • Excellent career progression opportunities

  • Work-life balance initiatives

  • Bonus scheme

  • Health insurance

  • Pension

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 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 Viatris we offercompetitivesalaries benefitsandan 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.


Required Experience:

Manager

McDermott Laboratories LimitedViatris 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 eve...

About Company

Company Logo

Viatris is a global pharmaceutical company that believes in healthcare not as it is, but as it should be. Learn about our story, explore our products and browse career opportunities.

View Profile View Profile