Senior Technical Writer/Business Analyst

1/2016 – 6/2016

Worked on the submission for the FDA, with focus on the CMC section.
Became familiar with structure of pharma QA systems.
Summarized documents and technical descriptions in order to produce product overview in compliance with CMC standards, working with minimal supervision and adhering to a tight project-plan.
Proof-read non-authored CMC sections.
Liaised with Regulatory staff and scientist on a regular basis.

Content Management

10/2015 – 12/2015

Worked on the Policy Framework project to update manuals and procedures.
Developed and proof-read IT infrastructure documentation with focus on compliance.
Worked in conjunction with SOP owners to review and rewrite the SOPs.

ITIL