This role is responsible for the leadership and management of the MI&E team(s) in the NoCC Site. This role holds accountability for the MI&E team delivering high quality, scientifically accurate, compliant, & timely responses to requests for information from Healthcare Professionals (HCPs).
About the Role
Associate Director, Medical Information & Engagement (MI&E) Team Lead NOCC
Location Hyderabad #LI Hybrid
Major Responsibilities
- Co-Leading the development and implementation of standards to ensure quality, accuracy and compliance with industry standards and practice codes in collaboration with USMA Medical Information and Engagement Leadership. Acting as designated business contact for MI&E systems in alignment with the USMA MI&E team
- Responsible for maintaining quality and consistency of responses to Medical Response Documents (MRDs). Responsible for any required financial management for the team. Leading the MI&E team, including identifying & sourcing new talent, retaining current staff, effective performance management of all MI&E line reports and effective skills development
- Provide day-to-day leadership & management of a high performing team of MI&E associates. Allocate appropriate MI&E resources appropriately to meet the business needs. Ensure operational and functional excellence. Share best practices.
- Participate in exploration of AI/Automation opportunities to optimize processes and enhance delivery of Medical Information documents and responses.
- Ensures compliance and inspection /audit readiness Ensure adherence to US regulatory and pharmacovigilance requirements and ensure compliance with MI&E standards and codes of practice. Responsible for enhancing and maintaining quality, consistent, scientifically accurate, well written responses to HCP inquiries
- Ensure responses to reactive requests are responded to in a timely fashion according to pre-defined KPIs. Co-develop performance metrics and key performance indicators (KPIs) to demonstrate and optimize quality and productivity
- Responsible for monitoring KPI and improvement management of the team, as needed. 100% compliance with legal regulations, industry codes and internal compliance standards
- Collaborate with functional Med Inquiry teams in the US and Mexico City, Proactive communication and managing and meeting stakeholder expectations Identify areas for operational improvement and promptly address any issues. Recommends suitable solutions, manages implementation of remediation plans when necessary
Minimum Requirements
Minimum Qualification Degree in a healthcare field required
Preferred Qualification Advanced degree (PhD, PharmD, MD) in life science/healthcare
- 5 7 years experience in a Medical Information role specifically in the Pharmaceutical Industry (or a related Medical Affairs role with significant MI responsibility in the Pharmaceutical Industry)
- Past successes in leading a MI team responsible for US specific deliverables
- Product and disease area knowledge in Novartis therapeutic areas
- Strong knowledge of good practices in medical enquiry management, medical information writing, and medical content review
- Experience in managing MI content requests across multiple therapeutic areas
- Demonstrated ability to recruit, develop and retain people
- Demonstrated influencing and leadership skills in a matrix organization
Preferred Requirements
- Strong comprehension of US language, terminology, culture, and ability to interpret information
- Prior experience and knowledge of Medical Affairs
- Strong understanding of the US Marketplace, US Healthcare Policy and Regulations, and US Healthcare Landscape
- Ability and willingness to travel internationally, up to 30%
- Willingness to work and be available during US business hours (up to 800 p.m. IST or 1030 a.m. EST), schedule coordination in advance to ensure US Holiday coverage, and on call for critical matters, based on business needs.
