Offers “Abbott”

Expires soon Abbott

Medical Writer II

  • Internship
  • USA
  • Sales

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 103,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Job Description:

Overview

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 (Abbott Diagnostics Division) 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.
  • Travel: None

Accountability/Scope/Budget

  • 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.

REQUIRED QUALIFICATIONS

  • 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 ADD(Abbott Diagnostics Division) products desirable.
  • Knowledge of regulations and standards affecting IVDs and Biologics.
  • 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.

     

JOB FAMILY:

Medical Writing

     

DIVISION:

ADD Diagnostics

        

LOCATION:

United States > Abbott Park : AP01 Floor-1

     

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), Keyboard use (greater or equal to 50% of the workday)

     

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

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