Abbott Medical Writer II 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.
Additional Main Responsibilities
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.
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.
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.
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.
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.
May recommend and implement process improvements.
Responsible for implementing and maintaining the effectiveness of the Quality System.
Drafts domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for new diagnostic assays and instruments.
Coordinates activities with product development teams to ensure goals are met.
Expected to meet quality standards for accuracy and completeness.
Works independently with some supervision.
Assisted and directed by the Medical Writing Section Head, as needed.
Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.
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 2 years relevant professional experience, in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing. 1-4 years writing experience as a medical writer in the health care industry preferred. 1-4 years experience in experimental design and data interpretation preferred. Knowledge of AMD products desirable. Good written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy. Fluent in word processing, flow diagrams and spreadsheets. Good working knowledge of personal computer software programs in Windows environment. Good communication, interpersonal, and team skills. Ability to critically review own work before sending out for internal/external review by team.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com