Primary Job Function
Prepares/assists with clinical research documents containing technical data in support of AMO’s medical device product lines. Documents may include literature reviews, clinical evaluation reportsand plans, clinical study reports. Communicates with other writers, clinical study managers, engineers, project managers, regulatory associates, product safety etc. to correctly incorporate technical content. Completes document format and layout.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1) Prepare or assist generation of literature reviews, clinical evaluation reports (CERs)/plans (CEPs), and clinical study reports (CSRs).
Assist literature searches (reviewing/appraising, summarizing/analyzing clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation
Collect and compile available clinical evidence for CER updates (clinical study outcomes, post-market surveillance data, PMCF updates, etc.), completion of post-market clinical reports(PMCRs) for product surveillance, maintenance of CERs/CEPs and CER/CEP updates in a document control management system.
Prepare/assist clinical study report generation by tracking and maintaining raw data tables/listings from biostatistics, drafting text, formatting tables, compiling final documents.
Incorporate text, tables, graphs, charts, statistical analyses, etc. into clinical documents in a clear and accurate manner with proper formatting.
Work in a team with other clinical research personnel and external medical writers for generation of clinical documents.
2) Maintain compliance with corporate policies, state, federal and international regulations.
Minimum Bachelor’s of Science (BS); prefer MS or PhD degree
Minimum Experience/Training Required
At least 1 year of experience with generation of clinical evaluation reports and/or clinical research documents or 4 years of general experience in technical/medical writing. Note: Less than 1 year writing experience with advanced degree (M.S. or higher) may be acceptable.
Proficient/expert in Microsoft WORD (version 2010 or later).
Ability to read/understand clinical literature (knowing where to find certain information in a scientific article to import into Distiller)
Ability to format WORD documents including styles, tables, cut and paste text/tables without formatting errors, etc.
Nice to have:
Clinical Research experience, particularly >1 year experience writing clinical research documents (e.g. CSRs)
Experience writing CERs
Ability to synthesize/analyze/summarize clinical data from literature and/or clinical study data tables
General understanding of medical device development