Job Description
The Regional Medical Information (MI) Manager provides strategic and operational support to the region to meet Global Medical Information (GMI) objectives. They build partnerships to align Affiliate Medical Affairs with AbbVie GMI Headquarters. They advise on best practices for product support, including product launches, and present region-specific analytics reports to stakeholders. This role acts as a liaison for product issue management and collaborates with Pharmacovigilance, Product Surveillance and other stakeholders. Additionally, they contribute to new hire training, manage vendor compliance, and work to optimize processes across Affiliates and regions.
Responsibilities
Triage Management and Inquiry Escalation:
* Act as the country/region point of contact for resolving escalated inquiries, ensuring that issues are addressed efficiently as per internal Turnaround Time (TAT) standards.
* Manage the escalation process for complex medical inquiries, working closely with the vendor team and GMI to ensure timely and accurate responses.
Content Development and Management:
* Ensure that all MI content is accurate, compliant with regulatory requirements, and aligned with strategic objectives.
* Develop and update local MI content as appropriate.
* Manage the translation of MI content to ensure it is accessible to all regions, considering local language nuances and regulatory requirements.
* Execute the quality monitoring plan for medical information in alignment with the GMI monitoring plan.
MI SME for Local Considerations:
* Serve as the subject matter expert for local business considerations, including Data Privacy, Pharmacovigilance, Regulatory Affairs, and other local regulations.
* Maintain Data Privacy Requirements per region/country
* Provide guidance and support to local Affiliate stakeholders to ensure MI activities comply with local regulatory requirements and organizational policies.
* Oversee the implementation of digital solutions to enhance MI capabilities and processes in the region.
* Lead and implement initiatives to integrate digital tools and platforms into MI operations, ensuring alignment with GMI goals.
* Analyze data from medical inquiries to generate insights and develop analytical reports.
* Present insights to regional and Affiliate stakeholders, providing trends and highlighting pertinent topics of interest.
Trainings and Forums:
* Coordinate, facilitate and deliver product, system and process training for the vendor team.
* Update training materials regularly to reflect changes in processes, regulations, and GMI goals.
* Actively participate in MI forums and Affiliate Medical Affairs/local Medical Operations meetings,
sharing insights, best practices, and updates relevant to the Affiliate, regional and GMI landscape.
Qualifications
* Attention to detail and excellent analytical aptitude and clear, concise communication skills both verbally and in writing.
* Researching, analyzing, and evaluating medical information materials using critical thinking skills and interpreting and applying medical information, instructions, policies and procedures and guidelines pertaining to medical communications and release of medical communications.
* Familiarity with pharmaceutical principles, practices and their application, comprehension of medical terminology and treatment modalities and knowledge of pharmacology principles, theory and their application.
* Capacity for driving process improvements and maintaining high-quality standards.
* Experience in leading cross-regional initiatives and coordinating between diverse teams.
* Sensitivity to cultural differences and an awareness of differences in medical and clinical practice in the region.
* Fluency in English and an appreciation of the difficulties and ambiguities in English language usage in the region.
* Knowledge and experience in use of computer systems and database and software applications, including Microsoft Office, Power Point, and Excel preferred.
Qualifications (education and experience)
* Minimum of B.S. degree with an emphasis in Science, Health Care or related fields from an accredited college or university and/or 2+ years of pharmaceutical industry experience (MI experience preferred) or 4+ years of health care related field experience.
* Experience can be appropriate internships or residencies.
* Advanced degree (PharmD, PhD) with at least three years pharmaceutical or related experience would be preferred.
* Working knowledge of current regulatory requirements (e.g. European Medicines, Pharmaceutical and Devices Agency, Food and Drug Administration), and/or other guidelines and knowledge of AbbVie therapeutic areas and research interests desired.
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.
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