Mandy Mortensen

Manager, Regulatory Operations at Assembly Biosciences

Mandy Mortensen has worked in various roles in the biotechnology and pharmaceutical industry. Mandy started their career at Sonia T Martinez BioMedical LLC as a Lead TMF Specialist from January 2015 to September 2015. Following that, they joined STM BioMedical LLC as a TMF Project Manager from September 2015 to December 2018. Mandy then moved to Ultragenyx Pharmaceutical Inc., where they worked as a Sr. Clinical Document Specialist from December 2018 to June 2020. Currently, Mandy is employed at Assembly Biosciences, Inc. as a Manager, Regulatory Operations, starting from June 2020.

Mandy Mortensen's education history includes a Bachelor of Science degree in Business Management from Brigham Young University - Idaho. Mandy attended this institution, but the specific start and end years are not provided.

In 2009, Mandy attended the University of California, Berkeley, where they studied Molecular Biology. Mandy completed their studies at this institution in 2012, although their degree name is not specified.

In 2020, Mandy obtained a certification in Clinical Research Conduct and Management from UC Berkeley Extension.

In terms of additional certifications, Mandy obtained various qualifications related to their field. In 2021, they received the Veeva Vault for Submissions System Administrator certification from Veeva Systems, as well as the ICH GCP E6 (R2) Good Clinical Practice for Sponsors and CROs certification from Barnett International. In 2020, they obtained the eCTD Advanced Workshop certification from the Regulatory Affairs Professionals Society (RAPS), as well as the RAPS Member certification from the Regulatory Affairs Certification Program. Additionally, in 2020, Mandy completed the Veeva Platform System Administrator certification from Veeva Systems and received the Good Clinical Practice Certificate from The National Institute on Drug Abuse (NIDA). Although a Regulatory Affairs - Pharmaceutical Certificate is mentioned, there is no specific information regarding its completion date or institution.

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Timeline

  • Manager, Regulatory Operations

    June, 2020 - present