Regulatory Data Governance Data Steward

Location : Budapest

Flexible working : 60% office, 40% home

Job type : Permanent, Full-time

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join our global Global Regulatory Operations team as a Regulatory Data Governance (DG) Data Steward and you’ll be responsible for driving Data Governance Requests to completion for changes to Regulatory data, formats, standards, and controlled vocabularies within Regulatory systems.

You will be a key member of a highly productive team, a collaborative team player, and driven by problem solving to support Sanofi’s ambition to be a data and digital driven organization.

Main responsibilities :

Prepare analysis and coordinate with Data Owners, System Owners, vendors, and ITS to investigate and analyse DG Requests, including impacts and related issues resolution

Ensure implementation of the change directly, or in coordination with ITS

Enforce and support DG processes & works to ensure DG Requests are resolved, and that the details and decisions are fully documented in the DG request tracker and other reference documentation

Support system integrations with Regulatory systems, including providing mapping of data between systems and resolution of data related issues between systems

Govern the data business rules, objects and fields, formats, definitions, and dictionaries, picklists, controlled vocabularies

With Business Data Owners define & document data model, data formats, and data related business rules

Maintain Regulatory Information Management (RIM) dictionaries in system, maintain and prepare dictionary content

Author, maintain and review Data Governance Job Aides describing detailed Data Steward activities

Promote data literacy and understanding of our data, definitions and standards with Data Owners, Regulatory Affairs, and other Sanofi organizations

Investigate industry and regulatory standards & requirements related to changes and updates, also data formats and controlled vocabularies

About you

Experience :

3 years pharmaceutical related experience in an analyst role / function is preferred

Experience with pharmacovigilance, clinical data, data management or related will be considered

Experience with Pharmaceutical Regulatory Data and Standards and data analysis is an asset

Background in Pharmaceutical Regulatory Affairs and Quality Operations is preferred

Soft Skills :

Ability to embrace new activities with demonstrated continuous improvement mindset

Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness

Ability to operate with agility in a dynamic global environment, with multifunctional and multicultural teams

Ability to propose solutions and proactivity with good organisational skills

Ability to maintain discretion and confidentiality about sensitive data

Strive to meet short deadlines and shifting priorities

Technical skills :

MS Office- Outlook, Excel, Word, PowerPoint & SharePoint

Veeva Vault is desirable but not essential

Education :

BSc. in Life Sciences or Regulatory Affairs (or equivalent)

Languages :

Strong English skills (verbal and written), ability to exchange fluently in a global environment

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment.

Work from an "Office of the Year 2023" award winner with flexible home office policy.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks.

Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).

Pursue Progress . Discover Extraordinary .

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing : a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

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