Medical Writer - Pharma

Executes medical writing activities for projects in accordance with applicable US and international regulatory regulations and organizational requirements under the supervision of the Manager, Medical Writing.  Assumes primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submissions, and assists the manager in coordinating and evaluating the activities of other contributors. Assists the manager in formulating writing approach, developing timelines, and assessing resource requirements for key documents and regulatory submissions. Participates on relevant project teams and task forces, and provides guidance to clinical, safety, nonclinical, and CMC functions on a wide range of issues related to document preparation and production, including US and international regulatory guidance and requirements for content and format, organizational requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents. 

 

Education and Experience

 

Required:

? Bachelor?s degree in science, health profession, or journalism.

? 3-5 years experience writing for pharma or biotechnology.

? Experience as lead writer for key documents included in major regulatory submissions.