Bhawna Basin
Angestellt, Senior Medical Writing Manager, Trilogy Writing & Consulting GmbH
Abschluss: Master of Pharmacy, Delhi Institute of Pharmaceutical Sciences & Research, University of Delhi
Frankfurt am Main, Deutschland
Werdegang
Berufserfahrung von Bhawna Basin
Bis heute 1 Jahr und 6 Monate, seit Jan. 2023
Senior Medical Writing Manager
Trilogy Writing & Consulting GmbHWriting and reviewing of various regulatory documents like Clinical Study Reports (CSRs), Common Technical Document (CTD) summaries, Clinical Study Protocols, Investigator Brochures (IBs), and Briefing books. Leading high complexity BLA submissions. Oversee and coordinate multiple medical writers and QC specialists Advise clients on the writing and planning of complex projects. Mentor less-experienced medical writer
Lead medical writer responsible for planning, coordinating, writing and reviewing of various regulatory documents like Clinical Study Reports (CSRs), Common Technical Document (CTD) summaries (Summary of Clinical Pharmacology, Summary of Clinical Efficacy, Summary of Clinical Safety, and Clinical Overviews), Clinical Study Protocols, Investigator’s Brochures, and Briefing Books. Managing a team of 6 medical witers (line management; oversight of professional development for individuals within the eam).
4 Jahre und 4 Monate, Sep. 2015 - Dez. 2019
Medical Writer
Trilogy Writing and Consulting, Frankfurt, Germany
My writing portfolio includes: 1. Regulatory documents: writing submission documents - Modules 2.7.1, 2.7.2, 2.7.3 and 2.7.4, study reports, study protocols, and narratives. 2. Publications: manuscripts, abstracts, and posters.
5 Monate, Juni 2012 - Okt. 2012
Manager Regulatory Affairs
Merck Sharp & Dohme, India (Merck & Co. Inc.)
2 Jahre und 8 Monate, Nov. 2009 - Juni 2012
Associate Regulatory Affairs
Merck Sharp & Dohme, India (Merck & Co. Inc.)
1 Jahr und 6 Monate, Mai 2008 - Okt. 2009
Technical Data Associate (Biologicals)
Central Drugs Standard Control Organisation
2 Jahre und 6 Monate, Nov. 2005 - Apr. 2008
Lecturer Pharmaceutics
Delhi Institute of Pharmaceutical Sciences & Research, University of Delhi
Ausbildung von Bhawna Basin
6 Jahre und 5 Monate, Juni 1999 - Okt. 2005
Pharmaceutics
Delhi Institute of Pharmaceutical Sciences & Research, University of Delhi
Dosage Form Design, Pharmaceutical Technology & Pharmaceutics
Sprachen
Englisch
Fließend
Deutsch
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