Start Date
Immediate
Expiry Date
12 Oct, 25
Salary
0.0
Posted On
13 Jul, 25
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Good communication skills
Industry
Information Technology/IT
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.
As SEND (Standard for Exchange of Nonclinical Data) project manager 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.