Medical Writer II

Job description

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 107,000 colleagues serve people in more than 160 countries

     

JOB DESCRIPTION:

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.

Our location in Abbott Park, Illinois currently has an opportunity for a Medical Writer II .

WHAT YOU’LL DO

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. 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.
·  You will be accountable for meeting our compliance standards including FDA, OSHA, and Abbott policies and procedures.
·  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.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

·  Bachelor's degree in Science or Medical Technology, English or equivalent experience.

Preferred

·  American Medical Writers Association
·  (AMWA) certification is desired, with a specialty in Editing/Writing for IVD Medical Devices.
·  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 ADD 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.
·  Submission writing for BLA,PMA and 510k, for Transfusion or Biologics.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

·  Training and career development , with onboarding programs for new employees and tuition assistance
·  Financial security through competitive compensation, incentives and retirement plans
·  Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
·  Paid time off
·  401(k) retirement savings with a generous company match
·  The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

JOB FAMILY:

Medical Writing

     

DIVISION:

ATM Transfusion

        

LOCATION:

United States > Abbott Park : AP03

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

     
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf