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Friday, 25 April 2014

Medical Writer II

Medical Writer II 
PAREXEL International - Bangalore


Job Description :
Essential Function
Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as primary technical contact with client under appropriate departmental supervision.

Qualifications :
  • Attend internal technical team and client team meetings as required.
  • May provide guidance to less experienced departmental members.
  • Supervise collection of materials by the Medical Writing Assistant or Associate Medical Writer for assembly of client deliverables and for filing appropriately in project files.
  • May participate in departmental or interdepartmental process improvement and training initiatives.
  • May participate in development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
  • Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.

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