Head Data & Documentation Nonclinical Submissions

Job title:

Head Data & Documentation Nonclinical Submissions

Company:

AstraZeneca

Job description

Job Title: Head Data & Documentation Nonclinical submissionsGrade FLocation: Barcelona, SpainSalary: Competitive & Excellent Benefits PackageJoin us as the head of our Nonclinical Data & Documentation team, where you will be responsible for delivering technical quality nonclinical submissions for the entire AstraZeneca portfolio throughout the product life cycle. You’ll lead a dynamic global team supporting a diverse pipeline. Harnessing our data is a key component of our strategy; in this role, you’ll innovate the way AZ manages our nonclinical data, exploiting opportunities to automate processes and generate further value while meeting ever-evolving health authority requirements for nonclinical submissions.Accountabilities:As the leader of our global team of documentation specialists and SEND specialists, you will be responsible for the delivery of submission-ready standard documentation across the full suite of nonclinical study reports. You will prioritize across the portfolio and submission activities to meet dynamic timelines and ensure the team is abreast with new developments and global health authority technical requirements for nonclinical submissions. Your role will also involve matrix leadership – internal cross-functionally and with our external CRO partners. You will innovate to develop new ways of working and exploit automation opportunities. Lastly, you will be responsible for nonclinical archiving; seek and retrieval of non-clinical data.Essential Skills/Experience:

• MSc or PHD or equivalent in a biomedical science field

5 years’ experience in nonclinical safety

• Line management experience and team leadership within a highly matrixed environment

• Pharmaceutical industry experience with an understanding of pharmacological, toxicological and pharmacokinetic principles and their application in regulatory submissions

• Understanding of submission requirements for major global health authorities (FDA, EMA, MHRA, PMDA), ICH guidelines and their application

• Experience with CDISC & SEND, regulatory document management systems eg Veeva Vault

• Proven project management skills

• Demonstrated ability to set and manage priorities, resources, goals and project timelines

• Highly developed influencing skills and interactive communication when interacting with people at all levels

• Ability to communicate effectively (written and spoken) in English

Desirable Skills/Experience:

• RAC or equivalent

• Experience implementing automation / ML / AI solutions for document & data management

• Familiarity with nonclinical archiving requirements including seek/find/retrieval

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. It’s our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way.Ready to embrace new and varied opportunities to develop and learn? Apply now and join us in our mission to follow the science and make a difference in the world!*Please apply with an English ResumeDate Posted 14-ago-2024Closing DateAstraZeneca 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.

Expected salary

Location

Barcelona

Job date

Fri, 16 Aug 2024 06:59:37 GMT

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