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Medical Writer I (Remote)

Employer
AbbVie
Location
Lake County, Illinois
Start date
May 9, 2022

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Job Details

  • Description

    We have an exciting and unique opportunity to join a large pharmaceutical company and be instrumental in the drug development process.  This entry-level medical writing position will prepare you to achieve the skills to successfully write a variety of clinical regulatory documents across multiple therapeutic areas.  We provide an energetic atmosphere of learning with structured training that will enable you to be hands-on writing clinical regulatory documents so that you can quickly be part of bringing new medicines to the patients who need them.  If you are someone who wants to make a difference, is looking for new and various learning opportunities, and likes to achieve great things, apply now!

    The medical writer is responsible for providing clinical regulatory document support to clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the clinical writing process.  Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area or potentially across a therapeutic area.  Interfaces with external groups (e.g., Pharmacokinetics, Toxicology, eSubmissions, Regulatory, Statistics, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions. Participates in process improvement activities.

    Key Responsibilities

  • Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated regulatory documents (US and ex-US).  Develops a strong knowledge of US and international regulations, requirements, and guidance associated with document preparation and submissions.
  • Serves as the Medical Writing representative on project teams.  Communicates deliverables needed, writing process, and timelines to team members.  Ensures all electronic document deliverables are processed and compiled in alignment with timelines.
  • Understands sources of information.  Seeks out information to ensure complete documentation of all inputs.  Converts relevant data and information into a form that meets regulatory document requirements.  Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables.
  • Verifies that results are consistent with protocols.  Explains data in manner consistent with the target audience and regulatory requirements.  Challenges conclusions when necessary.
  • Confirms completeness of information to be presented.  Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs.
  • Arranges and conducts review meetings with the team.  Acts as interface to resolve issues and questions arising during the writing process.
  • Performs literature searches as needed for drafting document content.
  • Works with manager throughout the RQA document audit process and works with team to draft responses as necessary.
  • Participates in process improvement activities.

Company

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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