Job Description

WE ARE LOOKING FOR CLINICAL MEDICAL/TECHNICAL WRITER III 6 MONTHS CONTRACT ROLE ALPHARETTA GA. Will 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.

SKILLS FOR CLINICAL MEDICAL/TECHNICAL WRITER III:

EDUCATION

·         Bachelors or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.

EXPERIENCE

·         Up to 2 years of as a medical writer in the medical device industry or

·         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.

·         Technical quality or engineering/R&D experience in a regulated industry, preferably medical devices. Experience writing engineering protocols, reports.

·         Experience writing regulatory submissions and/or participating in audits (preferred).

·         Able to grasp technical concepts and convey information in a clear, concise manner.

·         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).

RESPONSIBILITIES FOR CLINICAL MEDICAL/TECHNICAL WRITER III:

·         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.

·         Sit side-by-side and work with several members of our team to create in-depth processes maps and standard works for processes that are relatively simple to fairly complex.

Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials.

·         Excellent technical writer/engineer/scientist needed to generate test protocols, data collection, and test reports for medical device testing.

·         Broad technical understanding and clear, concise writing skills required. Individual should be comfortable working with various team members to shadow them during testing and inspection and document work instructions, test processes, test data, and results as well as draft reports including conclusions.

·         Various team members will provide review and editing suggestions for the various documents and individual should be able to work closely with those team members to implement changes quickly and efficiently.