Medical Writer

Responsibilities:

•      Setting, discussing and meeting expectations of the document during kick off and subsequent meetings

•      Lead the authoring/editing of clinical documents, as mentioned above.

•      Ensure adherence to established processes, timelines, regulatory guidelines and applicable standards, styles, guidelines 

•      Perform quality review of the clinical documents within established timelines with adherence to applicable guidelines, templates, and processes

•      Ability to effectively and proactively communicate with internal and external stakeholders, including authors and key opinion leaders as appropriate (including problem-solving and resolution of issues)

•      Keep abreast of project status, clinical operating plans and ongoing/new studies as well as scientific literature within assigned project.

•      Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards.

•      Training and mentoring of the new recruits/existing medical writers.

•      Oversee live projects assigned to the new medical writers and guide them as required.

•      As required, take on functional role and responsibilities of the role of  documentation Lead.