•Post graduate who combined studies with work and other professional commitments. In achieving this, I have shown myself to be self-motivated, committed and determined.
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•Demonstrated negotiating and organizing skills, a firm sense of responsibility and my capacity to work hard under pressure.
•Possess excellent verbal and written communication skills and able to relate to a wide range of people, as proven by my varied work experiences.
•Ambitious individual with three plus years experience in two different roles. 1 year 20 months as a...
•Analyze and interpret medical/scientific data and convert into document of required format. Comprehensive literature/information searches both externally and internally.
•Produce (research, write, edit, and review) high quality clinical, regulatory, scientific reports, manuscripts, training manuals, training slide decks, short reports, abstracts, posters and medical communication material including clinical regulatory documents such as clinical trial protocols, clinical study reports, investigator brochures, informed consent forms, INDs and IMPDs according to ICH and other guidelines.
•Write and review Clinical (Module 2 and Module 5) and non clinical sections (Module 2 and Module 4) of the Common Technical Document (CTD), upgrade existing documentation to appropriate CTD format.
•Prepare toxicological safety assessment reports (FDC) documents.
•Coordinating with other disciplines e.g., Safety Assessment and Chemistry manufacturing and control (CMC) units.
•Writing and review of variety high quality regulatory documents including Protocols and CSRs. Preparation/review of tabular data summaries and study listings tables for ongoing submission support.
•Completion of 2 year periodic updates of the documents to ensure that they reflect a contemporary understanding of each product.
•Develop and maintain necessary templates, formats and style guides to ensure that documents generated meet client requirements.
•Registering dossiers, package inserts and...
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