Manager - Regulatory Affairs Submission Systems and Support (Hybrid)

Company Description

About AbbVie

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 . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

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.

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.

Qualifications

Minimum Qualifications

• 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

Preferred Qualifications:

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

Other Required Skills:

• Strong communication skills, both oral and written
• Strong analytical skills and attention to detail

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• 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. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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