• Job Description

  Req#: R00085543

  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. The medical writer: provides medical writing expertise for multiple compounds
  and/or projects within a therapeutic area or potentially across a therapeutic areas; 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 and participates in process improvement activities.

  Responsibilities:

  • Implements all activities related to the preparation and compilation of data and information into a
    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.

  
  

  Qualifications:

  • Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or
    communications, with relevant science experience. Advanced degree preferred.
  • May have 1+ years relevant industry experience in medical writing in the healthcare industry or in a related
    area such as quality, regulatory, clinical research, or product support/R&D.
  • Developing knowledge of international regulations, requirements, and guidance associated with document
    preparation and submissions.
  • Ability to assimilate and interpret scientific content and translate information for appropriate audience.
  • Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency,
    clarity, and accuracy.
  • Experience in working with collaborative and cross-functional teams. Acts as interface to resolve issues and
    questions arising during the writing process. Identifies issues impacting team alignment across responsible
    functional areas and implements resolutions to resolve team discord.

  
  

  AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

  
  

• About the company

  AbbVie is an American publicly traded biopharmaceutical company founded in 2013.

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