Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Objectives

Be an experienced and pragmatic Medical Affairs professional with a strong focus on achieving excellence in Medical Compliance, Medical Operations and overall performance.Be the subject matter expert in material review, ensuring all materials follow regulations and legislation and comply with CGR guidelines.Build and maintain effective internal networks with key stakeholders to enable effective collaboration in material review process.Ensure AbbVie medical local operating procedures and work instructions are in accordance with the latest legislation and (self)regulation codes and implement efficiencies in our processes.

Key responsibilities
Compliance:

Serve as the primary contact person for medical review of materials.Establish and foster effective relationships with key stakeholders to facilitate seamless collaboration in the material review process.Be the content expert for the material review system and continuously improve system knowledge of medical and brand team partners.Ensure adequate understanding and knowledge of medical compliance within the teams involved in the approval process of materials.Provide regular training and/or case discussions to ensure knowledge of the teams stays up to date.Ensuring AbbVie medical Local Operating Procedures (LOPs) and Work Instructions (WIs) are in accordance with the latest legislation and (self)regulation codes.Continuously work with our key stakeholders to improve the knowledge of legislation and (self)regulation codes and agility of our material review process.

Medical Operations

Provide operational support to Medical functional priorities in alignment with the Head of Medical Operations & Patient Experience.Responsible for operational support to Pre-Approval Access (PAA) requests, ensuring actions taken by different functions, timely release of Investigation Product, andResponsible for maintaining local medical onboarding program that aligns with the local business needs and builds on existing MHI, CEX, and HR resources.Keep medical peers updated of changes to affiliate LOP’s, work instructions and guidelinesActively identify opportunities to enhance efficiency of our medical processes and implement process improvements.Where possible, be part of international initiatives in design and improvement of current and new systems.
Qualifications
Bachelor or master in pharmacy/life science/ or equivalent, preferredExperience in the healthcare/pharmaceutical industry as medical advisorExperience in material review and in-depth knowledge of CGR, legislation, regulationsFluent in Dutch and English (written/spoken).Excellent capabilities with standard IT office tools

Competencies

Strong analytical skillsPragmatic can-do attitudeFlexible and accurateHigh level of accuracy and attention to detailExcellent interpersonal skillsSeeks to simplify and removes bureaucracyRaises the bar and is never satisfied with the status quo
Additional Information

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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html