AbbVie Senior Medical Writer, Regulatory Writing in Lake County, Illinois

Description:

The Senior Writer is responsible for providing regulatory strategic document support to the regulatory teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the writing process. Partnering with the Global Regulatory Lead/Area Regulatory Lead, the senior writer provides regulatory strategic writing expertise for multiple compounds and/or projects within a therapeutic area.

  • Serves as a department representative and regulatory strategic writing lead on project teams, partnering with the Global Regulatory Lead and Area Regulatory Lead to prepare a high-quality, clearly messaged document founded in regulation and supported by the science. Works closely with Regulatory on document strategies
  • Interfaces with external groups (e.g., PK, Toxicology, CMC, Statistical Support, Data Management, Clinical, eSubmissions, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions. Communicates deliverables needed, writing process, and timelines to team members
  • Coordinates the review, QC, approval, and other appropriate functions involved in the production of regulatory projects. Arranges and conducts review meetings with the team
  • Assesses resource needs as timelines progress and communicates those needs to department management
  • Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors. Ensures required documentation is obtained
  • Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables. Ensures all regulatory electronic document deliverables are processed and compiled in alignment with timelines. Converts relevant data and information into a form that meets regulatory document requirements
  • Explains data in manner consistent with regulatory requirements. Confirms completeness of information to be presented. Challenges conclusions when necessary
  • Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs
  • Independently resolves document content issues and questions arising during the writing process
  • Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to regulatory documents
  • Implements tactical process improvements

Qualifications:
Required: * Bachelor of Science required, with significant relevant writing experience, or Bachelor's degree in English or communications, with significant relevant science experience * 3 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D * High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required Preferred: * Master's or PhD in science discipline preferred with relevant writing experience * American Medical Writers Association (AMWA) certification with a specialty in Editing/Writing or Pharmaceutical, or other relevant certificate * 2 years of experience in experimental design and clinical/preclinical data interpretation preferred * Knowledge of US and international regulations, requirements and guidance associated with scientific publications or regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations * Knowledge and expertise with Common Technical Document content templates * Knowledge of current electronic document management systems and information technology * Excellent written and oral communication skills. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience * Working knowledge of statistical concepts and techniques * Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy * Expert in word processing, flow diagrams, and spreadsheets * Excellent working knowledge of software programs in Windows environment * Extensive experience in working with collaborative, cross-functional teams, including project management experience Key Stakeholders: * RA management * Global Regulatory Product Team members and their associated Regulatory Leads * R&D functional management and members involved in generating regulatory submission documents

Job Classification: Experienced
Job: MEDICAL
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Schedule: Full-time
Shift: Day
Travel: Yes, 10 % of the Time
Req ID: 1706813

Equal Opportunity Employer Minorities/Women/Veterans/Disabled