Medical Writer

Job description

-Compiling, writing, reviewing and editing medical writing deliverables (clinical study protocols and clinical protocol amendments, informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions, Investigator Brochures, as well as clinical journal manuscripts, clinical journal abstracts, posters, literature reviews and client presentations) for a variety of audiences with minimal supervision

 

-Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency

 

-Ensuring the accuracy of all information, data and referencing for the publications/documents produced

 

-Working on a variety of projects at the same time

 

-Understanding new therapy areas quickly and comprehensively

 

-Working closely with clients, physicians and investigators

 

-Contributing ideas for business proposals and new projects

 

-Mentoring and leading less experienced medical writers on complex projects, as necessary

 

-Adhering to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget

 

-Maintaining familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing

Summary

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