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Section Head

4 months ago

Chicago, United States Abbott Laboratories Full time

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbottâs 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 â 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. Youâll 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 student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs 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 the Section Head, Medical Writing within the Regulatory Affairs Dept. of our Transfusion Medicine Division of Core Diagnostics

This position has primary management responsibility to prepare and compiles technical documents and labeling to support complex US and international medical device regulatory submissions (i.e., International In Vitro Diagnostic Regulatory [IVDR] submissions, Investigational New Drug [IND] applications, and Biologics License Applications [BLA]).

Highly experienced in medical or scientific writing, with strong written and verbal communication skills. Recruits, develops, and manages a team of medical writers.

WHAT YOUâLL DO:

  • Coordinates all activities related to the preparation and compilation of data, labeling, and information into a single comprehensive package for new and revised US and international medical device regulatory submissions.  Challenges conclusions when necessary.
  • Effectively develops and communicates timelines to manager and collaborates with R&D, Regulatory Affairs, Quality, Clinical Affairs, and Medical Affairs in completing project-related deliverables required for submissions.
  • Determines format for submissions and documents that enhance the ease with which the information can be understood. Interprets and explains data generated from a variety of sources, including internal experiments, research documentation, and clinical data. Explains the data in a manner consistent with the target audience and regulatory requirements. Confirms completeness of information to be presented.
  • Coordinates responses to inquiries, questions, and deficiencies received from submission reviewers both in the US and internationally.
  • Acts as interface to resolve issues and questions arising during writing process. Recommends and implements process improvements. 
  • Manages group or small department, providing direction and guidance to exempt and non-exempt personnel. Evaluates performance and assists in career development planning for personnel.

âThis is an onsite position.

EDUCATION AND EXPERIENCE YOUâLL BRING:

Experience:

Individual executes and manages medical writing activities.

Must function independently as a decision-maker and assure that deadlines are met.

Effectively communicates, prepares, and negotiates with internal business partners.

Work is performed without appreciable direction and individual exercises some latitude in determining objectives of assignments.

Individual is recognized as a discipline expert and resource in medical writing .

Required Education:

Bachelorâs 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.

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.

 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, and presentation software. Familiarity with timeline creation/project management.

Proficient in critically reviewing own work before sending out for internal/external review by team. 

Knowledge of regulations and standards affecting IVDs and Biologics.

Preferred:

Experience with Biological License Applications (BLA) and/or IVDR Technical Documentation is preferred.

Ability to motivate external team members to produce submission deliverable.

Apply Now

* 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



The base pay for this position is $95,000.00 â $190,000.00. In specific locations, the pay range may vary from the range posted.