
Manager, Regional Medical Information
- Maidenhead, Berkshire
- Permanent
- Full-time
- 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.
- 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.
- 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.
- 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,
- 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.
- 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.