Section Head - Medical Writing
Abbott Laboratories - Chicago, Illinois, United States, 60290Work at Abbott Laboratories
Overview
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Overview
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 DiagnosticsThis 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 YOU’LL 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.This is an onsite position.EDUCATION AND EXPERIENCE YOU’LL 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: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.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
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The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.
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