Himakshi Sharma
Angestellt, Global Program Associate Director, Novartis
Abschluss: Masters of Dental Surgery, PDM Dental college
India, Indien
Werdegang
Berufserfahrung von Himakshi Sharma
Bis heute 3 Jahre und 1 Monat, seit Juni 2021
Global Program Associate Director
Novartis
4 Jahre und 4 Monate, Feb. 2017 - Mai 2021
Regulatory writer
Novartis
Individual content contribution and stakeholder management for CTD Modules 2 and 5 majorly including clinical study reports (CSRs), clinical overviews (COs), and clinical summaries for submission to regulatory authorities in support of marketing applications
7 Monate, Juli 2020 - Jan. 2021
Global Program Management (Sabbatical)
Novartis
1 Jahr, März 2016 - Feb. 2017
Senior Scientific Associate
Phamax
Project Management: Preparing project proposals and strategy and interaction with the clientele for project requirements and deliverables Project Deliverables: Scientific/health projects such as market access assessment, epidemiological studies, treatment assessment studies, cost of treatment studies for multiple disease areas, access to therapies etc.
2 Jahre und 3 Monate, Jan. 2014 - März 2016
Senior Medical Writer
Apcer lifesciences
Project Responsibilities and Deliverables: CTD Modules 2, 4 and 5 majorly including COs, non-clinical overviews, clinical summaries and non-clinical summaries for generic product filings. Investigator brochures, protocols, safety narratives, and CSRs for USFDA. Summary of product characteristics, patient information leaflets, clinical expert statement for EMEA (generic and innovator) filings and risk management plans. Briefing documents for USFDA submissions
Ausbildung von Himakshi Sharma
8 Monate, Mai 2013 - Dez. 2013
Clinical Research and Pharmacovigilance
Cliniminds
5 Jahre und 3 Monate, Aug. 2006 - Okt. 2011
Bachelors of Dental Surgery
PDM Dental college
Medicine and Dentistry
- Bis heute
Project and risk management
University of Virginia
Sprachen
Niederländisch
Grundlagen
Englisch
Fließend