Associate Director, Global Medical Information And Medical Review

hace 4 días

Barcelona, Barcelona, España Medical Assistant A tiempo completo
Job Summary

We are seeking a highly skilled and experienced Associate Director to lead our Global Medical Information and Medical Review team. As a key member of our Medical Affairs department, you will be responsible for managing the development and implementation of medical information and review processes, ensuring compliance with regulatory requirements and industry best practices.

Key Responsibilities
  • Develop and maintain a deep understanding of therapeutic areas, including pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned products and disease states.
  • Lead the review and approval of promotional and non-promotional materials, ensuring scientific and medical accuracy, relevance, and completeness of data.
  • Collaborate with cross-functional teams to ensure alignment of medical strategy and promotional materials.
  • Provide medical and scientific expertise to commercial teams for disease and product claims development.
  • Develop and maintain a strategy for the development and review of global medical information response documents.
  • Plan and facilitate training for medical information contact center associates and lead medical information booth activities at professional scientific meetings.
  • Proactively distribute important product and medical information to relevant internal functions and enhance medical and product knowledge within the Sales Force, Marketing, Field Medical, and other departments.
  • Systematically compile, assess, maintain, and communicate metrics that monitor Medical Information trends.
  • Achieve and maintain compliance with all applicable regulatory, legal, and operational rules and procedures.
Requirements
  • Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD) with a minimum of 5 years of medical information, medical affairs, or relevant experience in the pharmaceutical or biotech industry.
  • 3 years of relevant experience in reviewing and approving US promotional and/or non-promotional materials.
  • Experience with drug development, health authority regulations, and reporting requirements.
  • Experience with the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts.
  • Proficient in collaboration, negotiating, and influencing skills.
  • Excellent written and verbal communication skills.
  • Highly proficient in literature searching skills.
  • Highly detail-oriented in the development and review of medical information response documents.
  • Self-motivated to drive for results, with strong organizational and planning skills.
  • Highly proficient with Microsoft Office Suite.
  • Ability to travel to meetings and conferences (domestic and international) approximately 10% of the time.
Preferred Qualifications
  • Experience providing global medical information/medical communication support within a global function.
  • Experience reviewing and approving global promotional and non-promotional materials.
  • Experience developing (or overseeing the development of) materials utilized by Medical Affairs in the context of scientific exchange.
  • Experience leading medical information or medical review initiatives for a product launch.
  • Training or past experience in assigned therapeutic areas or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapies.
  • Demonstrated project management skills.
  • People management experience.
  • Prior experience working with medical information or medical communication systems/databases.

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