Associate, Regulatory Affairs Submission Management
AbbVie
18 days ago
Remote friendly (Florham Park, NJ)
United States
$65,500 - $125,500 USD yearly
Corporate Functions
Associate, Regulatory Affairs Submission Management
Responsibilities:
- Manage low to medium impact submission projects to deliver timely, high-quality dossiers meeting regulatory technical specifications and easy to review.
- Provide RA Submissions support to project teams with guidance on established submission processes and standards; input to publishing timelines and deliverables.
- Coordinate and expedite multiple concurrent activities for low to moderately complex published submissions; anticipate obstacles and propose solutions.
- Coordinate submission publishing with offsite publishers; prepare content planners for publishing; work with vendor to resolve publishing issues; may perform in-house publishing tasks.
- Facilitate creation/procurement of submission deliverables (e.g., cover letters and forms); perform quality reviews (content, bookmarks, hyperlinks, tables of contents) for compliance.
- Contribute to business process and standards development for publishing and deliverables; implement internal process/standards documents.
- Suggest and contribute to process improvements, including software and business process changes; may support internal project teams updating business software.
- Influence without direct authority; build and maintain internal/external relationships.
Qualifications:
- 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).
Benefits (explicitly listed):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for short-term incentive programs.
Application instructions:
- None provided.
Responsibilities:
- Manage low to medium impact submission projects to deliver timely, high-quality dossiers meeting regulatory technical specifications and easy to review.
- Provide RA Submissions support to project teams with guidance on established submission processes and standards; input to publishing timelines and deliverables.
- Coordinate and expedite multiple concurrent activities for low to moderately complex published submissions; anticipate obstacles and propose solutions.
- Coordinate submission publishing with offsite publishers; prepare content planners for publishing; work with vendor to resolve publishing issues; may perform in-house publishing tasks.
- Facilitate creation/procurement of submission deliverables (e.g., cover letters and forms); perform quality reviews (content, bookmarks, hyperlinks, tables of contents) for compliance.
- Contribute to business process and standards development for publishing and deliverables; implement internal process/standards documents.
- Suggest and contribute to process improvements, including software and business process changes; may support internal project teams updating business software.
- Influence without direct authority; build and maintain internal/external relationships.
Qualifications:
- 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).
Benefits (explicitly listed):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for short-term incentive programs.
Application instructions:
- None provided.