Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:* Writes and edits Clinical Study Reports (CSRs), and other documents for submission to regulatory agencies and prepares other regulatory and clinical trial documentation as necessary.
* Compiles, analyzes, and summarizes data from statistical tables and other sources as needed.
* Assembles CSR narratives.
* Edits, rewrites, or otherwise prepares drafts of Clinical Protocols and Investigator Brochures.
* Requires knowledge of company's product areas, current developments, and keeping abreast of current literature.
* Study contact on relevant regular and ad hoc project teams as required.
* Determines methods and procedures on new assignments.
* Performs a variety of other tasks as required.
EDUCATION/EXPERIENCE/SKILLS:
* BS/BA degree in life science or physical sciences or higher-level qualification preferred; or equivalent combination of education and industry experience.
* Strong written communication skills.
* At least three years pharma or biotech industry experience preferred
* Experience and significant participation in preparation of documents for regulatory submissions (e.g., Clinical Protocols, INDs, NDAs, BLAs, CTDs) preferred.
* Familiarity with therapeutic area of oncology is desirable.
* Experience and use of electronic literature tools to obtain reprints of abstracts and medical publications.
* Familiarity with document management systems is desirable.
* Identifies and implements methods and procedures to achieve results.
* Has understanding and wide application of applicable technical principles, theories, concepts and techniques.
* Has good general knowledge of other related disciplines.
* Applies strong analytical and business communication skills.
To find out more about Real please visit www.realstaffing.com