Medical Writer - ThinkCentric

Location: Farmingdale, NJ
Categories: Clinical
Website: http://thinkcentric.com

Position Description

We have an opening for a Medical Writer/Sr. Medical Writer, permanent position, at a Biopharmaceutical company offering a special environment, and known for its outstanding staff.

Responsibilities include, but are not limited to, the authoring and editing of scientific and medical documents required during the drug development process, this includes, but is not limited to, IND, NDA and BLA sections, Common Technical Document, Investigator Brochure, Protocol, Protocol Amendments, Informed Consent Documents, integrated clinical and statistical Clinical Trial Reports, IND Annual Reports, journal articles, and abstracts and posters; preparing documents that have high quality scientific content, organization, clarity, accuracy, format and consistency with adherence to guidelines; taking an active role with respect to the planning of content, format, and timing of documents, report scheduling and tracking; providing support to the assigned clinical development team to ensure that project needs and department standards are met, while completing reports within established schedules and timelines; interacting effectively with team leaders, project physicians, statisticians, programmers and regulatory personnel, and facilitating effective interactions and information exchange/communication among co-authors/reviewers as appropriate; keeping abreast of project status, clinical operating plans and ongoing/new studies as well as scientific literature within the assigned area; maintaining/developing knowledge of regulatory guidelines, technological advances, and industry standards, and participating in other tasks as required.

BS/BA in biology, nursing or relevant discipline; training in computer applications, GCPs, medical terminology and the drug development process. 4+ years of medical writing experience required. Must be detail oriented, possess excellent writing organizational and communication skills and the ability to work as a member of an integrated team. Experience with electronic publishing of documents an asset. Must be computer literate in MS Windows-based applications.

How to Apply

Please respond by email to Pat Dowens, Director of Clinical Research recruiting. pdowens@thinkcentric.com

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