Senior Medical Writer

The Senior Medical Writer will write, edit and/or manage the production of high quality clinical documentation (e.g. Clinical Study Reports and Summary Documents) for submission to regulatory authorities in support of marketing applications.  The incumbent will act as a member of clinical trial teams following protocol finalization and write/edit clinical study reports or parts thereof.  Participate in planning of analysis and data presentation to be used in study reports or summary documents.  Act as documentation consultant in clinical trial teams to ensure compliance of documentation to internal company standards and external regulatory
guidelines.  Write/edit summary documents for submissions or parts thereof (e.g. CTD safety and efficacy summaries and Clinical Overviews), under supervision.  Act as program medical writer for various programs in clinical development and ensure medical writing resource allocation to studies within these programs. May act as submission coordinator to ensure provision of adequate medical writing resources for dossier preparation and coordinate production of summary documentation by medical writing team in collaboration with clinical team.  Act as liaison between clinical trial teams and coDOC publishing and/or DRA operations to ensure timely delivery of final documents for publishing.  Supervise outsourcing to external medical writers.  Requirements include a life science degree or equivalent.  Excellent written and oral skills.  At least two years medical writing experience.  Good data interpretation and presentation skills.  Solid knowledge of clinical documentation. Good understanding of statistics. Good knowledge of regulatory requirements. Good knowledge of clinical development. Experience in managing external medical writers and knowledge of document publishing.

Please refer to job code TP6626 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Other Pharmaceutical
Location:	Livingston, NJ
County:	Essex County
ZIP Code:	07039
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856