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SEND Expert (all genders)
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role:
As SEND (Standard for Exchange of Nonclinical Data) expert you are an integral member of the Chemical and Preclinical Safety Team and work closely with the study directors/study monitors, external SEND conversion vendors, CROs and consultants. The coordination of the operational SEND activities for internal and external studies is one of your main responsibilities. Within our function you are the first point of contact for all SEND-related questions. In addition, you are responsible for keeping the SEND processes and stakeholders aligned to current and future requirements regarding SEND by liaising with relevant stakeholders and SEND-related organizations. This includes efficiently driving the implementation of new SEND requirements, which directly impacts our submission readiness. Overall, you ensure that the SEND data packages and processes are compliant with relevant guidelines/regulations (e.g., CDISC, SEND IG, FDA Business Rules), budget, and timelines.
Who you are:
- Master´s degree or PhD in life sciences and proven experience in clinical or nonclinical data management, ideally experience with SEND
- Experience in creation/handling of CDISC datasets and standards, preferable SEND
- Good background in SEND relevant guidelines and regulations (e.g., CDISC, SEND IGs, FDA Business Rules, TCG)
- Prior project leader/management experience
- Fluency in written and spoken English combined with a sense of organizational psychology which allows to meet people where they are
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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