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Medical Writer - United States  

Aequor Technologies (company)

Posted on : 22 December 2017

Project Description


• Minimum of 12 years but 15 - 20 yrs preferred experience of regulatory writing and submission experience
• Management experience preferred

Responsibilities will include, but are not limited to, the following:

• Support development of clinical submission documents, eg, CSRs, CTD summary documents (module 2.7), and Clinical Overviews (2.5); prepare and manage, create and/or review
• May need to lead submissions or new programs
• Respond to HA questions as needed (eg, prepare response documents)
• Prepare IBs and other documents to support clinical programs
• Any other related tasks as may be required by Client, eg, review of documents and QC as needed
• All services performed shall be in accordance with Client's SOPs/WPs
• A contract medical writer may be assigned to one or more documents and may have a lead or supportive role