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R&D Principal Data Integrity and Compliance Professional (Principal Professional), Ballerup

Created 12/17/2021
Reference 476931510
Category Pharmaceutical
Job type Full Time
Country Denmark
City Ballerup
Zip Not specified
Salary Competitive
LEO Pharma has embarked on a very ambitious journey to become the world's preferred dermatology care partner. You will enter LEO Pharma at the most exciting period of time. Right now we are transforming our business and ways of working to meet the requirements of tomorrow and our corporate 2030 strategy.

Global Research and Development (R&D) is at the forefront of this journey - and that is why we need you.
We drive the execution of all of LEO Pharma's drug discovery, design and development together with stakeholders across LEO Pharma as well as external partners around the world.

This role is ideal for a candidate who has a passion for working in the intersection between R&D science disciplines and the world of data and advanced technology. In this position you will drive and ensure compliance with data integrity and data privacy measurements (confidentiality, integrity, availability, safety, privacy and business continuity/recovery). You will be taking ownership and being in the forefront of a digital transformation journey, driving the agenda of strengthening and unlocking the potential of data not only within R&D but also across the wider LEO Pharma.

Your new challenges

As a Principal Data Integrity and Compliance Professional within R&D you will take lead in defining and executing on the R&D Data Strategy with focus on data integrity and compliance. You will use your deep insights and you will know and understand the needs of the business. You will use your knowledge to partner up and engage with your stakeholders which include senior Subject Matter Experts and Leadership teams and defining/paving the way in terms of how R&D build and maintain robust business ethics around use of data across. In doing so, you will drive the value generation of data, unlocking data potential by growing knowhow and shared competencies around data ethics and documentation across the R&D Line of Business.

Key responsibilities include:
  • Engage as close collaboration partner to the Line of Business on data Integrity, Data Privacy and Compliance related matters
  • Establish generic QMS frame and processes for how to work compliant with data across R&D in various technical solutions and in complex infrastructure (confidentiality, integrity, availability, safety, privacy and business continuity/recovery for data in e.g. data lake)
  • Evaluate and advise the R&D Line of Business on Data Integrity, Data Privacy and Compliance risks associated with technologies, systems and software, providing solutions for robust preventative actions in utilizing data across.
  • Help conduct needed risks assessments associated with use of data from R&D in e.g data lake solution, e,g Business Impact Assessments, GxP Assessments, Data Integrity Risks Assessments and DPIAs etc.
  • Establish and maintain processes for audit trail reviews, create and maintain data/document flows and procedures for security/access control in R&D data lake solution.
  • Establish guidance's and training material, catering for educational needs of the broader R&D Line of Business of data ethics and standards.

Your new team

R&D have recently formed a unit "R&D Data & Analytics" to bring data-driven processes into our critical business paths, utilizing data, building systems and applications to drive new business opportunities gaining faster and more effective decision making, based on data insights. We serve a two-fold purpose modernizing current drug development processes by focusing on more data-driven approaches and seeking out entirely new opportunities for business in dermatology using platform technologies which are data-driven at its core.

You will work in a cross-functional team with Line of Business subject matter experts and technical experts. The team is responsible for building and delivering use cases to support a data driven R&D. As part of the new unit you and the team around you are responsible for building smart and sustainable data products in close collaboration with the end users.

You will become part of a team with a pleasant and flexible work environment, a team that have full speed ahead whilst staying open minded and social.

Your qualifications

Our ideal candidate has a master's degree in Life Sciences, Computer Science or Engineering or related field.

You have at least 6-8 years of relevant experience from an R&D competency area or as a minimum the pharmaceutical industry, where you have been acting in the intersection between business and IT/advanced technology.

With a minimum 2-3 years of project management and/or leadership experience, you have shown strong leadership capabilities (e.g. ability to set direction, ensure project progress, motivate, challenge and create a winning spirit amongst team members)

It will be a must that you have deep insight and experience within data integrity and data privacy compliance, preferably both within operations and IT/tech projects.

It will be an advantage if you have previous experience with participation in or have had supportive roles during internal audits or Health Authority inspections.

As a person show leadership and not least ownership of the initiatives and projects you involve yourself in. You generally show a high visibility and are capable of influencing and impacting without direct authority.

You are highly customer focused and a true team player that value close collaboration with your colleagues. You are curious of nature, challenging the status quo, and are not afraid of taking part in discussions and decisions, driving efficient decision making processes.

Excellent proficiency in English will be an expectation together with the ability to navigate across cultural and professional diversities.

Join our mission to help more people achieve healthy skin

Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people's lives around the world and at the same time create profitable growth.

Contact and application

If you have questions, please do not hesitate to contact Troels Ravn Bærentzen, VP Head of R&D Data & Analytics, at +45 41 85 17 21.

Please apply via the link at our website and remember to attach application and CV. The deadline is 07. February 2022.

About LEO Pharma

LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.