Associate, Regulatory Affairs Submission Management
AbbVie
18 days ago
Remote friendly (North Chicago, IL)
United States
$65,500 - $125,500 USD yearly
Corporate Functions
Associate, Regulatory Affairs Submission Management
Responsibilities:
- Manages low to medium impact submission projects to ensure timely delivery of high-quality dossiers meeting regulatory technical specifications.
- Supports project teams with submission processes and standards; provides input to publishing timelines and deliverables.
- Participates in submission team meetings; coordinates concurrent submission activities, anticipates obstacles, and proposes solutions.
- Coordinates submission publishing with offsite publishers; prepares content planners for publishing and works with vendors to resolve publishing issues; may perform in-house publishing.
- Facilitates creation/procurement of submission content deliverables (e.g., cover letters and forms).
- Performs detailed quality reviews of published output for compliance (content, bookmarks, hypertext links, tables of content) and facilitates team reviews.
- Contributes to business process/standards improvement for high-quality submissions and supports implementation of publishing standards.
- Suggests process improvements, including software and business process changes; may join teams to update business software.
- Influences without direct authority; builds and maintains internal/external relationships.
Qualifications:
- Required: Bachelor’s Degree; 2 years pharmaceutical or industry-related experience.
- Preferred: Publishing-related software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat).
Additional information:
- Hybrid schedule: 3 days in office (North Chicago, IL or Florham Park, NJ).
- Significant work activity: continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hr day).
Responsibilities:
- Manages low to medium impact submission projects to ensure timely delivery of high-quality dossiers meeting regulatory technical specifications.
- Supports project teams with submission processes and standards; provides input to publishing timelines and deliverables.
- Participates in submission team meetings; coordinates concurrent submission activities, anticipates obstacles, and proposes solutions.
- Coordinates submission publishing with offsite publishers; prepares content planners for publishing and works with vendors to resolve publishing issues; may perform in-house publishing.
- Facilitates creation/procurement of submission content deliverables (e.g., cover letters and forms).
- Performs detailed quality reviews of published output for compliance (content, bookmarks, hypertext links, tables of content) and facilitates team reviews.
- Contributes to business process/standards improvement for high-quality submissions and supports implementation of publishing standards.
- Suggests process improvements, including software and business process changes; may join teams to update business software.
- Influences without direct authority; builds and maintains internal/external relationships.
Qualifications:
- Required: Bachelor’s Degree; 2 years pharmaceutical or industry-related experience.
- Preferred: Publishing-related software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat).
Additional information:
- Hybrid schedule: 3 days in office (North Chicago, IL or Florham Park, NJ).
- Significant work activity: continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hr day).