Simin Takidar

I am a Principal Medical Writer with over 13 years of experience in regulatory medical writing and project management. I have authored and reviewed the following documents for submission to various regulatory authorities (FDA, EMA, PMD and some national Health Authorities): Clinical Study Reports (CSRs), Clinical Trial Protocols, Investigator’s Brochures (IBs), Plain Language Summaries for CSRs, patient narratives, Informed Consent and Assent documents, Investigational New Drug Application (IND) annual reports, New Drug Application (NDA) annual reports, Periodic Adverse Drug Event Reports (PADERs), Periodic Safety Update Reports (PSURs; including associated benefit risk summaries), Clinical Overviews (Module 2.5), summaries of clinical efficacy and safety (Module 2.7) and integrated summaries of safety and efficacy (Module 5.3.5.3). 

I have worked in dynamic environments with agility, a sense of urgency, with a patient- and client-centric approach and a solution-oriented mindset. I have strong communication skills, and the foresight to anticipate and mitigate upcoming challenges, and to add value with innovative and actionable insights. I have successfully managed projects in electronic document management systems and collaborated with clinical project teams to steer documents to completion.

I have contributed as a subject matter expert (SME) for clinical trial transparency/disclosure since 2019. My responsibilities as a clinical trial transparency/disclosure SME have included oversight of registration and disclosure tasks on CT.gov and EudraCT, contribution to EMA (policy 0070 and CTIS) and Health Canada offerings, and preparation of Plain Language Summaries. I have also worked with internal teams on Requests for Proposal (RFP) and Requests for Information (RFI) from clients, and have liaised with potential vendors and clients to build the clinical trial disclosure portfolio. Starting January 2022, I am an SME Instructor for the Medical Writing module for the Parexel Academy/IU University of Applied Science program for a Masters of Business Administration in Clinical Research.

I have continually received client and senior management appreciation as a Lead Medical Writer on CSRs, Protocols, and Common Technical Document (CTD) submission documents. I was awarded a global performance award as lead medical writer for a submission CSR in 2014, and the Medical Writing Service Award for Excellence for my contribution as a clinical trial transparency/disclosure SME, and Lead Medical Writer on a Full Service Project for a large pharmaceutical client in 2021.