Act as the medical writing expert responsible for the research, writing and editing of study level and submission level documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission. Responsibilities will include assuring quality and timely preparation of clinical documents across all therapeutic areas as assigned, including clinical study reports, clinical study protocols, investigator’s brochures, clinical summaries and overviews. • Assist the GMW TAH in the development of clinical document content used to support successful global clinical development, approval and marketing of a drug. • Implements the medical communication strategy for all regulatory submission documents as assigned. • Uses the Global Target Label (GTL) and all associated product strategy documents to effectively develop associated clinical documents in support of the Global Clinical Development Plan (CDP), validate individual study protocol design and clinical study report (CSR) key messages, and provide key messages for submission dossiers used to gain marketing approval for the assigned documents.• Implements project level data presentation and messaging standards for the assigned documents.• Independently authors submission and study level documents (collaborating with the team) based on the strategy provided and is accountable for the format, content and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
Bachelor's Degree with at least 5 to 6 years of experience in the pharmaceutical industry. A minimum of 4 years in medical writing and demonstrated working knowledge of scientific principles.
Must have experience in developing clinical documents in support of regulatory submissions globally in more than one thrapeutic area.
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Posted 4 years ago