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About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Assistant Regulatory Affairs
Ludwigshafen am Rhein, Germany Req ID 2205952 Category Administrative Services Division AbbVie
Your tasks
• Organizational and administrative routine activities of the Regulatory & QA department
• Administrative support of parallel sales and parallel import displays
• Electronic and paper-based storage and archiving
This includes:
• Independent handling of correspondence in German and English
• Support for meetings, business trips and external events using AbbVie systems: − Support of meetings - Assistance in the organization of appointments, invitations, room bookings , catering, document preparation and logging, follow-up meetings
− Organization of business trips (travel and accommodation) and travel expense reports, mediation of course bookings / seminar registrations
− Tracking of all department-relevant appointments
• Edit mail / mail
− Management of incoming and outgoing mail for the entire department
− Sorting and distribution of documents for mail, scans and emails from the authorities
− Submission, Archiving Regulatory Correspondence
• Parallel sales / import - management and documentation of incoming and outgoing samples
- Internal follow-up to ensure timely response to submission
− Support in the preparation of applications for authorisation
− Creation of status reports and measured values
− Tracking the SmPCs of AbbVie products on government websites and reporting any discrepancies
• Independent storage/archiving
- Paper-based storage in data rooms with maintenance of folder structures, marking
- Responsible archiving of the paper stock in digital form and transfer to external archives
• Other
− Quality control of all internal RA databases
− Documentation of training and further education measures for the entire RA department
- Manage the "list of absences" (holidays, illness and other absence dates) of the RA department
− Management of personnel, address, telephone and inventory lists
− Procurement of all office equipment (hardware and software, office supplies)
− Request for all technical services (maintenance, transport, repairs, etc.)
− Other administrative support as needed
Prerequisite(s):
• Training in the commercial sector or comparable training with appropriate experience
• Excellent german language skills (mother tongue or equivalent)
• English language skills (B2 or better)
• Independent and reliable way of working
• High sense of responsibility
• Strong ability to work in a team
• Very high service orientation
• Knowledge of Microsoft standard software
• Professional experience in pharmaceutical, ideally with a focus on regulatory and/or quality/complaint management
• Experience with parallel sales and import
• Knowledge of GxP regulations
• Experience in archive management/archiving
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