Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
PRIMARY FUNCTION / PRIMARY GOALS / OBJECTIVES:
Prepares technical documents to support both domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for diagnostic assays and instruments. Drafts and/or incorporates text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner.
Responsible for implementing and maintaining the effectiveness of the quality system.
Serves as the Medical Writing representative on product teams. Communicates deliverables needed and writing process to team members. Accesses resource needs as timelines progress, and communicates those needs to management. Utilizes submission templates (if available) and format/style guidelines established by Medical Writing. Obtains relevant product data and information. Converts relevant product data and information into a form that meets submission requirements. Reviews, circulates, edits, assembles, inspects, and duplicates product submissions. arranges and conducts review meetings with teams on submission and related labeling. Responsible for implementing and maintaining the effectiveness of the Quality System.
ACCOUNTABILITY / SCOPE:
Writes and edits domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for new diagnostic assays and instruments. Expected to meet quality standards for accuracy and completeness. Assisted and directed by the Medical Writing Manager, as needed.
THIS POSITION IS LOCATED AT OUR DES PLAINES, IL LOCATION.
Minimum 1 year relevant professional experience, in a related area such as R&D, Technical Product Support, Quality, Regulatory Affairs, Clinical Research, or Medical Writing. 1-2 years writing experience as a medical writer in the health care industry preferred. 1-2 years experience in experimental design and data interpretation preferred.
Knowledge of Abbott Molecular products desirable. Good written and oral communication skills. Good attention to detail. Familiar with word processing, flow diagrams and spreadsheets. Good working knowledge of personal computer software programs in Windows environment. Good communication, interpersonal, and team skills. Understands the need to critically review own work before sending out for internal/external review by team. Knowledge of regulations and standards affecting IVDs and Biologics.
Bachelor's degree in Science, Medical Technology, English, or equivalent experience.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Primary Location: USA-Illinois-Lake County
Travel: Yes, 20 % of the Time
CenterWatch - 22 months ago
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Filling baby bottles and treating disease... these are the habits of Abbott. Abbott Laboratories is a top health care products manufacturer....