Sr. Medical Writer - (Mahwah, NJ)

The role of the Senior Medical Writer is to ensure that all clinical study and submission documents for assigned projects are prepared, reviewed, and approved in a quality, timely and accurate manner such that the data presented will be appropriate for review by the agencies. The required responsibilities and task are: To prepare documents that are compliant with company's standards, ICH and GCP guidelines and that are approved by the project team, as appropriate. To plan, schedule and track all assigned medical writing activities in close cooperation with the teams to ensure high-quality, timely, and accurate completion of all documents at each point in the document life-cycle. To work with Medical Writing Management for regular project updates, production and review of assigned documents. To take responsibility for ensuring that medical writing deliverables meet the project specifications and produced within the timelines to defined quality, and content standards.