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Director, Regulatory Data

AstraZeneca UK

Location: Cambridgeshire

Job Type: Full time

Posted


Do you have expertise in, and passion for data governance, master data management, data quality and data standards? Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

About AstraZeneca

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Global Regulatory Operations

We are now looking for a Regulatory Data Director to join us in Global Regulatory Operations (GRO) within Regulatory Affairs. This is a growing area within a globally connected business, and a place to share learnings and best practices with our leading data teams within R&D. Working across our locations, therapy areas and external community means we’re comfortable stepping up, willing to take ownership of our work, in an effort to find solutions for the business and our personal career development.

The jobholder will be a member of the Regulatory Data Office (RDO), which is accountable for managing regulatory data assets on behalf of regulatory groups across AZ, in alignment with digitization strategies in Regulatory, R&D and across AstraZeneca. The RDO provides system and process agnostic data ownership of regulatory data, establishes strategic direction for regulatory data and recommends actions related to systems and process as they pertain to regulatory data.

What you’ll do

As a member of the Regulatory Data Office you will be responsible for one or more aspects of regulatory data, managing a specific portfolio of accountabilities based on priority, skills and needs.

Areas of accountability may include:

  • Data governance and policy: Establish and manage processes and frameworks to control regulatory data

  • Data quality: Implement programs to ensure high quality of regulatory data, and oversee the quality of regulatory data wherever it may reside

  • Data standards: Establish schema to ensure AZ has expertise and compliance with regulatory standards such as XEVMPD and IDMP

  • Master and Reference Data: Establish and control master and reference data in the regulatory domain, in alignment with AZ data strategy

Within the assigned area of accountability, you will implement and manage effective programs to maximize the value of regulatory data, increase usage across the AZ enterprise, prepare AZ for compliance with digital HA requirements and advance AstraZeneca’s digital ambitions.

With this in mind we think you have proven experience and technical capabilities deploying solutions in support of regulatory information management, in-depth knowledge of procedures and compliance standards governing the management of regulatory and/or pharmacovigilance data (e.g. IDMP, EVMPD, ICH M5, HL7), and knowledge of the regulatory and safety activities required to support drug development and marketed products.

Specific responsibilities may include:

  • Establishing and directing programs using innovative approaches

  • Connecting to data networks, representing RDO in AZ forums

  • Ensuring data is fit for purpose for external and internal customers

  • Establishing a culture of continuous improvement, high performance, flexibility and quality

  • Providing strategic direction to regulatory customers regarding data management

  • Engaging and influencing internal and external stakeholders

  • Representing the company externally in collaborations with industry partners or regulatory authorities

  • Directing and task-managing team members

  • Identifying and raising issues and risks, and proposing options to mitigate them

  • Functioning as data expert with understanding of governance, data quality, master and reference data

  • Establishing KPI and monitoring performance of data management practices to ensure delivery of business benefit

  • Demonstrating and contributing to a culture of data ownership and management

Education, Qualifications, Skills and Experience

Essential for the role:

  • Bachelor’s/Master’s degree in a scientific, business or information sciences discipline, and/or relevant experience in the bio-pharmaceutical industry

  • In depth knowledge of procedures and compliance standards governing the management of regulatory and/or pharmacovigilance data (e.g. EVMPD, ICH M5, HL7).

  • A broad understanding of Regulatory, Patient Safety and drug development activities and the challenges associated with managing data in support of critical business and compliance activities

  • Knowledge of the regulatory and safety activities required to support drug development and marketed brands, including a good understanding of relevant global regulations, pharmacovigilance guidelines, information standards and reporting obligations.

  • Able to identify opportunities and to instigate and lead change through innovation – seeking continuous improvement based on strong awareness of external practice.

  • Able to represent the company externally in collaborations with industry partners or Regulatory Authorities.

Desirable for the role:

  • Proven experience in data management, with a track record of developing solutions and services in this area.

  • Experience of delivering projects across the global enterprise and operating in a complex environment with multiple stakeholders.

  • Experience in developing strategic-enabling services and capabilities, or developing business information management solutions for a global enterprise.

  • Experience in working across business/company interfaces to manage information requirements

  • Highly developed strategic thinking, with ability to understand business needs & perspectives, and identify ways in which complex information sources can be used to achieve business goals.

  • Ability to acquire and assimilate knowledge in different disciplines and business areas.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save plans, A performance recognition scheme and a competitive, generous remuneration package.

Where can I find out more?

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Date Posted

15-Nov-2022

Closing Date

29-Nov-2022

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.