Manager - Regulatory Affairs Submission Systems and Support (Hybrid)

AbbVie • North Chicago, IL

1d • Hybrid

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. The Manager, Regulatory Affairs Submission Management is responsible for providing expert support and continuous improvement for all publishing systems used by the RA Submission Management team. Responsible for providing functional leadership in system upgrades, process enhancements, and large scale platform initiatives, while also fostering collaboration across global Submission Management teams. This role is responsible for ensuring robust and efficient operations, driving innovation, and advocating for timely delivery of technology solutions.

Requirements

• Bachelor’s degree (note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.)
• 6+ years of pharmaceutical or industry related experience with RIM and publishing related software tools (e.g. Documentum, Generis CARA, docuBridge, Toolbox)
• 1-2 years in cross functional project management
• Strong communication skills, both oral and written
• Strong analytical skills and attention to detail

Nice To Haves

• PMP and RAC certificates a plus
• Sharepoint related coursework/certifications
• Power Apps/Power Automate experience
• Power BI experience

Responsibilities

• Serve as the primary point of contact and subject matter expert for publishing related systems, providing day-to-day support and guidance.
• Partner with BTS to lead and execute system upgrades from the business perspective, including impact analysis, user acceptance testing, job aid updates, training and communication, and installation confirmation.
• Lead, develop, and maintain tools and templates for the Submission Management team.
• Possess a working knowledge of submission management business processes and associated regulations and using the knowledge, collaborate with global teams to enhance publishing processes and implement solutions.
• Prepares and delivers effective management communication that efficiently frames complex issues and leads to actionable decisions.
• Develop and deliver training documentation and provide end user training for new systems and processes.
• Actively drive and implement new ideas to enhance the effectiveness, quality, and efficiency of the Submission Management team.
• Foster open, constructive communication with stakeholders, transparently resolving conflict and leveraging feedback for improvement.

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager