Technical Writer II

Company: CorTech LLC
Location: Concord
Posted on: July 31, 2020

Job Description:

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 publications.


RESPONSIBILITIES
--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 adjudication processes
--Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials

Requirements:
--Bachelors or higher degree preferred; scientific focus desirable.
--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 Association.
--Up to 2 years of as a medical writer in the medical device industry
--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 presentations.
--Ability to create basic tables using AMA style (eg, Schedule of Events).
--Intermediate applied knowledge of basic clinical laboratory tests.
--Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
--Basic understanding of biostatistical and clinical research concepts.
--Regulatory Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).

Keywords: CorTech LLC, Concord , Technical Writer II, IT / Software / Systems , Concord, California