A Medical Writer applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe the research results, product use, and other medical information. Medical writers may also offer writing support to the principal investigators for grant applications and specialized publications.
Develops and modifies labeling for product labels, cartons graphics, implant cards, patient leaflets, inserts and other related material ensuring that they meet all medical, legal, and regulatory requirements for medical devices and drugs following the established design format, labeling style guidelines and branding standards. Leads and/or supports a cross-functional team collecting labeling content and translating it into a functional label layout utilizing labeling software and/or illustrating software. Works on commercialized and new product development products for all associated labeling requirements. Develops and manages labeling changes within the approved document management system. Designs product labeling considering such factors as product identification, worldwide requirements, sales appeal, aesthetic quality, printing, and production techniques. Manages multiple concurrent deadlines and prioritizes work independently. Supports all company initiatives as identified by management and in support of the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements. Complies with the U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO, Company Policies, Standard Operating Procedures (SOP), working instructions, and task assignments. Aids in the design and development of packaging prototypes and supports R D builds with labeling. Participates in Voice of Customer (VOC) activities through collaboration with Key Opinion Leaders (KOL's). Develops, maintains, and manages all packaging graphics and labeling utilizing electronic desktop publishing equipment. Performs other related duties and responsibilities, on occasion, as assigned
Must Have:
Adobe Illustrator Adobe InDesign Adobe Photoshop Labeling Compliance Medical Device Nice To Have:
