Abbott Sr Medical Writer in Abbott Park, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
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. Incorporates text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner. Confirms that data are presented in a clear, complete, accurate, and concise manner. Is recognized as being highly qualified in medical writing and is known for expertise within the department. May serve as an expert for the department for one or more submission types or product lines. Coaches and may supervise contract employees and more junior medical writers.
Core Job Responsibilities
Responsible forimplementing and maintaining the effectiveness of the quality system. Serves as the Medical Writing representative on product teams. Coordinates all activities related to the preparation and compilation of data and information into a single comprehensive package for new and revised domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for diagnostic assays and instruments. Communicates deliverables needed and writing process to team members. Communicates timelines 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. Assesses accuracy of information. Understands sources of information. Seeks out information to ensure complete documentation of all outputs. Converts relevant product data and information into a form that meets submission requirements. Reviews, circulates, edits, assembles, inspects and duplicates product submissions. Uses ADD manufacturing/ testing documentation systems. Determines format for submissions and documents. Interprets data, and verifies that results are consistent with protocols. Confirms completeness of information to be presented. Challenges conclusions when necessary. Confirms label and package insert claims are supported by and consistent with data presented in the submissions. Acts as interface to resolve issues and questions arising during writing process. Arranges and conducts review meetings with teams on submission and related labeling. Develops formats and presentations that enhance the ease with which the information can be understood. Coordinates responses to inquiries, questions, and deficiencies received from submission reviewers both in the US and internationally. Interprets and explains data generated from a variety of sources, including internal experiments, research documentation, charts, graphs, and tables. Explains the data in a manner consistent with the target audience and regulatory requirements. Develops consistent processes related to submission preparation, formats, and content. Recommends and implements process improvements. Leads process improvements. Coaches and assists contract employees and more junior medical writers. May also supervise the work of contract editors and medical writers. Takes a lead role in communicating their areas of expertise to department members. Negotiates milestones and due dates based on anticipated product launch dates.
Drafts domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for new diagnostic assays and instruments. Coordinates submission timelines division wide to ensure prompt and accurate completion of packages. Coordinates activities with product development teams to ensure goals are met. Consistently exceeds quality standards for accuracy and completeness. Works independently with little supervision. Assisted and directed by the Medical Writing Section Head, as needed.
Bachelor's degree in Science, Medical Technology, English, or equivalent experience. American Medical Writers Association (AMWA) certification is desired, with a specialty in Editing/Writing or Pharmaceutical.
Minimum Experience/Training Required Minimum 4 years relevant professional experience, in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing. 2-4 years writing experience as a medical writer in the health care industry preferred. 2-4 years experience in experimental design and data interpretation preferred. Knowledge of ADD products required. Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy. Expert in word processing, flow diagrams, spreadsheets, presentation software, and familiar with timeline creation. Good working knowledge of personal computer software programs in Windows environment. Excellent communication, interpersonal, and team skills. Proficient in critically reviewing own work before sending out for internal/external review by team. Knowledge of regulations and standards affecting IVDs and Biologics. Ability to motivate external team members to produce submission deliverables.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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