Technical Writer II
Company: CorTech LLC
Posted on: July 31, 2020
Technical Writer II
Pay Rate: $35.79/ HR
Cortech is looking for a qualified Clinical Medical/Technical
Writer to assist in the development, drafting, review, editing, and
finalization of documents used in conducting clinical studies and
reporting clinical study results for regulatory submissions and
--Drafts and edits documents used in conducting and reporting the
results of clinical studies, including protocols, protocol
amendments, informed consent forms, clinical study reports; and
technical dossiers Conducts comprehensive literature evaluations,
product complaint reviews, and other product specific information
to compile literature based clinical evaluation reports.
--Manages study team participation in the preparation of such
documents, including calling/running meetings, developing
timelines, and managing the document review and comment
--Provides peer review and editing support for other regulatory
documents, such as statistical analysis plans, CRFs, and other
--Bachelors or higher degree preferred; scientific focus
--University-level medical or technical writing course(s) or
equivalent experience in science/technical writing.
--Evidence of medical writing career development, eg, American
Medical Writers Association certificate, Editor in Life Sciences
certificate, or relevant training through Drug Information
--Up to 2 years of as a medical writer in the medical device
--At least 5 years of medical or scientific writing experience as a
primary job responsibility Medical Writing Experience writing,
reviewing, or editing protocols and clinical study reports and
literature based clinical evaluations highly preferred.
--Intermediate to advanced applied knowledge of routine document
content preparation, including the use of style guides, medical
dictionaries, and guidance documents that prescribe content.
--Intermediate to advanced applied knowledge of AMA, CBE, and
Chicago Style Manuals.
--Ability to interpret basic tabular and graphical clinical data
--Ability to create basic tables using AMA style (eg, Schedule of
--Intermediate applied knowledge of basic clinical laboratory
--Basic understanding of the concepts of coding dictionaries
(MedDRA, WHO Drug).
--Basic understanding of biostatistical and clinical research
--Regulatory Basic knowledge of regulatory requirements and
guidances associated with standalone regulatory documents (eg,
protocols, investigator brochures, and clinical study
Keywords: CorTech LLC, Concord , Technical Writer II, IT / Software / Systems , Concord, California
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