Senior Medical Writer

As a Sr. Medical Writer, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives. You will actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents. Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents. You will also Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate. Assist in defining and writing standard operating procedures and working practices to allow the effective and efficient preparation of quality documents. You may participate in cross-functional process improvement initiatives.