Experience

Corcept Therapeutics

• United States
• Biotechnology Research
• 200 - 300 Employee

• Associate Director, Medical Writing

  • Mar 2020 - Present

  Write and edit regulatory documents. Develop and lead medical writing projects including clinical study protocols, CSRs, and IBs. Organize medical writing department for consistency in submissions and standardization during review/approval processes among CROs and free-lance contract medical writers. Lead program sub-team meetings for assigning project roles, creating and overseeing project timelines, and establishing team objectives. Lead cross-functional team meetings for review of study data outputs. Develop protocol and Investigator's Brochure templates and clinical document SOPs. Project management in coordinating input from subject matter experts (such as pharmacovigilance/drug safety representatives, program MDs, and Regulatory Affairs personnel) for regulatory submissions. Show less



Stealth Bio Therapeutics

• Associate Director, Medical Writing

  • Mar 2018 - Jan 2020



Intarcia Therapeutics, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Principal Medical Writer

  • Apr 2015 - Feb 2018

  Authored regulatory documents and coordinated medical writing projects including clinical study protocols, CSRs, IBs, model subject informed consent forms, briefing book, and clinical sections of NDA, CTD modules. Represented Medical Writing Department in cross-functional project team meetings. Created project timelines. Managed medical writing projects outsourced to CROs. Organized medical writing department for consistency in submissions and standardization of processes among CROs and contract medical writers. Show less



BioBridges

• Business Consulting and Services
• 1 - 100 Employee

• Contract Medical Writer

  • Jun 2013 - Mar 2015



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract Medical Writer/Senior Medical Writer

  • Feb 2012 - May 2013



Alkermes

• Ireland
• Biotechnology Research
• 700 & Above Employee

• Senior Medical Writer

  • Feb 2011 - Sep 2011



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Medical Writer/Senior Document Manager

  • Oct 1996 - Dec 2010