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Medical Writing Document Associate I (Remote)

Employer
AbbVie
Location
Illinois
Start date
Feb 29, 2024

View more

Discipline
Clinical, Medical Writing
Required Education
Associate Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

  • Process, proofread, verify, and manage various clinical, regulatory, and pharmacovigilance documents ensuring they are submission ready for publishing with an appropriate level of accuracy.
  • Communicate regularly with colleagues and management regarding timelines and conflicts to timelines for word processing requests, eSubmission issues and document completion dates. Ensure all electronic document deliverables are processed and completed in alignment with timelines.
  • Ensure document format and style are consistent with defined eSubmissions format and styles, such that documents created in MS Word correctly render to PDF.
  • Confirm formats and styles are consistent with those in the clinical templates, when applicable. Creates and updates clinical templates as directed by the Submission Templates & Tools Team (STaTT).
  • Proofread documents for accuracy and consistency. Import and route documents in the eSubmission system ensuring proper document properties and correct naming conventions are used per the eSubmissions system file naming conventions.
  • Accurately and timely maintain document tracking for all documents. Ensure literature citations are correct. Perform literature searches.
  • Provide ongoing support for Medical Writers and others; act as a liaison between eDocs support and Medical Writing organization as needed. Function in an eDocs business support role.
  • Maintain strong knowledge of eSubmission styles and formatting standards. Coach and mentor more junior and contract Medical Writing word processors. Lead internal process improvement activities.
  • Act as word processing subject matter expert on cross-functional teams in support of related initiatives (e.g. system). Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.
  • Share oversight of word processing group mailbox, including scheduling word processing documents.

  • Bachelor or associates degree preferred; equivalent experience considered.
  • 5+ years word processing or clinical research/related field experience or equivalent.
  • Strong knowledge of word processing including: formatting, use of styles and templates, table formatting, use of styles and templates, table formatting, cross-referencing, bookmarking.
  • Strong knowledge and experience with Common Technical Document (CTD) content templates.
  • Experience with document checking, importation and workflows in electronic document management systems.
  • Excellent written and oral communication skills.
  • Superior attention to detail and ability to prioritize multiple tasks/projects.
  • High level computer skills. Proficient in electronic document management system. Excellent working knowledge of software programs in Windows environment.
  • Strong organizational skills; ability to work with minimal supervision.
  • Experience in working in collaborative, cross-functional teams.

Role may be done remotely anywhere in the US. 

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.


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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