Sofie Eg Hay-Schmidt

Experience

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  Bøgballe Friskole

  Aug 2014 - Jul 2015

  Childcare Assistant and Substitute Teacher

  As a childcare assistant and substitute teacher, I have been teaching and assisted children from 0. to 9. grade with their homework Moreover, I was permanent teacher for the 0. grade every friday from April to June.

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  Genmab

  Aug 2016 - May 2021

  Student Worker

  Student worker in the CMC department.Responsibilities includes - Stability trending and QC- Training in SAS JMP and of student workers- Assisting the CMC team members with various tasks ad hocFurthermore, I have assisted the department Communication and IR in the preparation of documents for the Annual General Meeting.

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  Horsens Svane apotek

  Feb 2020 - Jul 2020

  Stud. Pharm.

  As an intern at Horsens Svane Apotek I learned how to counsel patients about their medication and the use of this. I also learned how to perform medical reviews of patients’ various medications and assess the risks of drug-drug interactions.

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  Genmab

  Jul 2021 - now

  Responsibilities include:- Authoring of CMC regulatory sections of INDs and BLA/MAAs- Coordinate and support Q&As from HA- Coordinate and support authoring of CMC regulatory updates- Set out CMC regulatory writing and response principles Responsibilities include among others:- Monitoring and follow up on stability trends and setting expiry date- Part of creating stability protocols in cooperations with CMOs and project managers- Authoring regulatory submissions including contributions to BLA

  • Senior CMC Writer Associate

    Mar 2023 - now

  • CMC Pharmaceutical Technology Associate

    Jul 2021 - Mar 2023