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Remote Medical Writer

New Jersey All, New Jersey

Post Date: 03/06/2017 Job ID: JN -032017-18534 Industry: Medical Writing - Clinical
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 Celgene, eg, review of documents and QC as needed
All services performed shall be in accordance with Celgene s SOPs/WPs
A contract medical writer may be assigned to one or more documents and may have a lead or supportive role

Prerequisites:

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


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