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.
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.
- 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. Evidence of medical writing career development, e.g., American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
Fulfills one of the following: 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 (e.g., 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 guidance associated with standalone regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
Additional Job Details:
What youll do: 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 Test documentation for accuracy and consistency Identify areas that may require additional process improvements or documented structure and develop thoughtful recommendations for execution Utilize Great Plains ERP system to include graphical instructions along with written detail to deliver the appropriate level of detail for both audit purposes and new user training Provide regular communication and synchronization with multiple points of contacts at remote locations to provide updates to progress and deliver completion timelines What were looking for: Bachelor’s degree or equivalent experience in English, Communication, or Journalism. 2-5 years experience working as a Technical Writer or in related job role. Ability to analyze and synthesize complex content. Strong technical aptitude ability to quickly learn new concepts and tools. Excellent writing and proofreading skills. Ability to write clearly and succinctly for multiple audiences using either formal or more casual tones. Excellent work ethic and strong intellectual curiosity. Ability to work quickly, efficiently, and multi-task. Desire and ability to innovate and improve upon current processes. Experience creating infographics to more clearly communicate workflow processes and abstract topics Track record of effective collaboration Experience working with Subject Matter Experts (SMEs) both in-person and remote. Experience in prioritizing and understanding the lifecycle of documentation from pre-release through on-going maintenance. Experience creating infographics such as diagrams, screenshots, workflows, graphs, etc.