Medical Advisor Operations

We are looking for an experienced and pragmatic Medical Affairs professional to join AbbVie as a Medical Advisor Operations. In this role you will play a key part in ensuring medical materials meet all applicable legislation regulations and CGR guidelines. You will act as a subject matter expert in the material review process collaborate closely with internal stakeholders. You will support the efficient execution of Medical Affairs activities and you will also help maintain and continuously improve Medical NL Standard Operating Procedures and Work Instructions ensuring they remain aligned with evolving requirements and best practices. Your responsibilities will include:

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.
• Ensure Medical NL SOPs and WIs are in accordance with the latest legislation self-regulation codes and internal procedures.
• Continuously work with key stakeholders to improve knowledge of legislation and self-regulation codes and increase agility in the material review process.

Medical Operations:

• Provide operational support to Medical functional priorities in alignment with the Head of Medical Operations & Patient Experience.
• Process Pre-Approval Access (PAA) requests ensuring timely actions by different functions timely release of investigational product and compliance with procedures and legislation.
• Maintain the local medical onboarding program so it aligns with local business needs and builds on existing MHI CEX and HR resources.
• Keep medical peers updated on changes to affiliate SOPs work instructions and guidelines.
• Actively identify opportunities to enhance efficiency of our medical processes and implement process improvements.
• Perform periodic monitoring to check adherence to Medical NL procedures.
• Where possible be part of international initiatives in design and improvement of current and new systems.

Qualifications :

We are looking for a person who has:

• Bachelors or Masters degree in pharmacy life sciences or equivalent.
• Experience in material review and in-depth knowledge of CGR guidelines legislation and regulations.
• Experience as medical advisor in the healthcare/pharmaceutical industry
• Fluent in Dutch and English (written/spoken).
• Excellent capabilities with standard IT office tools
• Strong analytical skills
• Pragmatic can-do attitude
• Flexible
• High level of accuracy and attention to detail
• Excellent interpersonal skills
• Seeks to simplify and remove bureaucracy
• Raises the bar and is never satisfied with the status quo

Additional Information :

This is a hybrid position where your presence will be required at the office 3 days a week therefore you should live within commuting distance to the office.  We look forward to receiving your application!

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 :

No

Employment Type :

Full-time