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This is a critical function in a group with multiple clinical pipeline products.
Responsible for proper strategy for efficient medical writing and clinical document development functions.
– Responsible for coordination of medical writing processes, development and review of clinical study protocols, synopsis, study procedure manuals, independent review charters and clinical study reports, etc.
– Act as medical writing liaison to work with medical directors, clinical operations, biostatistics and data management and clinical QA and compliance
– Manages review process of all clinical documents, coordinates round table discussions if necessary
– Helps biostatistics and regulatory affairs groups in regulatory submissions
– Provides assistance in preparation of abstracts, manuscripts and other presentations for scientific and sales meetings
Education: Master’s Degree in a Biological or Health-Related Field, PhD Preferred.
1) Min. 5 years of related experience in the life sciences field, including 3 years of in a regulatory environment in the pharmaceutical, biotechnology or CRO industry.
2) Demonstrated proficiency initiating and managing clinical documentation projects. Experience in writing clinical protocols, study report, data monitoring charter, blinded read charters, imaging technical documents, manuscripts and publication materials.
3) Experience in preparation of NDA and IND required.
4) Familiarity with GCP, ICH and FDA regulatory requirements as they apply to clinical trials. Regular interaction with Clinical Operations, Biostatistics and Project Management.
5) Must be able to handle multiple demands and shifting priorities.
6) Excellent written and oral communication skills required.