Alex Marcheschi

Experience

• 

  PETNET Solutions

  Sept 2015 - Nov 2015

  Nuclear Pharmacist

  • Synthesized, quality tested, and shipped various radioactive biomarkers in a highly structured and fast-paced work environment.

• 

  Xerox

  Feb 2016 - Aug 2016

  Clinical Pharmacist

  • Determined Medicare Part D coverage exceptions on a drug-by-drug basis for members of Caremark insurance companies.

• 

  Synchrogenix, a Certara company

  May 2017 - Sept 2018

  Regulatory Writer

  • Authored and performed QC for a wide range of clinical regulatory documents, including CTD summary modules (2.7.1/2.7.2), CSRs, study protocols, patient safety narratives, and PK/PD modeling and simulation reports.• Received comprehensive regulatory writing and QC training.

• 

  Grifols

  Sept 2018 - Dec 2020

  • Managed a team including 2 staff writers and multiple off-site vendors for support with clinical trials disclosure (CT.gov and EudraCT), writing, and QC.• Served as the lead writer for clinical regulatory documents.

  • Manager, Medical Writing

    Nov 2020 - Dec 2020

  • Medical Writer I

    Sept 2018 - Nov 2020
• 

  Novavax

  Jan 2021 - Mar 2024

  • Represents the Medical Writing Department on cross-functional teams to develop SOPs and drive company initiatives.• Authors and manages timelines for clinical regulatory documents (eg, CSRs, CSPs, IBs, and BLA submission documents).• Writes and approves content for clinical publications (eg, manuscripts, abstracts, and poster presentations).

  • Associate Director, Medical Writing

    Apr 2023 - Mar 2024

  • Senior Manager, Medical Writing

    Apr 2022 - Apr 2023

  • Manager, Medical Writing

    Jan 2021 - Apr 2022
• 

  Moderna

  Mar 2024 - now

  Senior Manager, Medical Writing