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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Our location in Abbott Park, IL currently has an opportunity for a Senior Medical Writer within the Regulatory Affairs Dept. of our Transfusion Medicine Division of Core Diagnostics.

• Senior Medical Writer will be an individual contributor with comprehensive knowledge in the area of Medical Writing.

• 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.

WHAT YOU’LL DO :

• Responsible for implementing 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.

• UsesAbbott Diagnost 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.

​This is an onsite position.

EDUCATION AND EXPERIENCE YOU’LL BRING:

Experience:

• 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.

Required Education:

• 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.

Experience / Training Preferred

• Relevant profess ional 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 preferr ed.

• 2-4 years’ experience in experimental design and data interpretation preferred.

• 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 deliverable.

Apply Now (https://www.jobs.abbott/us/en)

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

The base pay for this position is $83,000.00 – $166,000.00. In specific locations, the pay range may vary from the range posted.

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 corpjat@abbott.com