Medical Advisor Operations

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 and
• Responsible 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 LOPs work instructions and guidelines
• Actively 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 preferred
• Experience in the healthcare/pharmaceutical industry as medical advisor
• Experience in material review and in-depth knowledge of CGR legislation regulations

• Fluent in Dutch and English (written/spoken).
• Excellent capabilities with standard IT office tools

Competencies

• Strong analytical skills
• Pragmatic can-do attitude
• Flexible and accurate
• High level of accuracy and attention to detail
• Excellent interpersonal skills
• Seeks to simplify and removes bureaucracy
• Raises 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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