Manager Regulatory Affairs Submission Systems and Support (Hybrid)
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
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
- Bachelors 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
