Director, Evidence Generation & Compliance

Job Description Summary

#LI-Hybrid

Novartis has an incredible opportunity for a talented individual to join our team as a Director Evidence Generation & Compliance. You will, be responsible for leading the safety and medical compliance function within the US Medical Affairs organization. Be responsible for direct and/or indirect management of people, as well as resource and budget management responsibility for their programs. Strategically partners with internal and external stakeholders to provide a center of excellence for Safety Risk Management and Medical Compliance across USMA.

This position is based is East Hanover, NJ and will not have the ability to be located remotely. Please note that this role would not provide relocation and only local candidates will be considered. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 25% travel.

 

Job Description

Key Responsibilities:

• Leads Medical Quality and Compliance within the department. 
• May serve as delegate for the ED/Head, Evidence Generation Excellence as requested. 
• Collaborates and aligns with colleagues on activities pertaining to the annual IRO monitoring and annual ERC monitoring of medical activities and annual risk assessment. 
• Collaborates with legal and ERC business partners as business needs dictate. 
• Oversees investigations and ensures team is reporting deviations and events, including driving corrective action plans. 
• Oversee appropriate follow-up and full execution/implementation and deviation management in appropriate system. 
• Accountable for audits conducted within the organization. 
• Serves as the safety risk expert on project/product teams throughout the product life cycle and contributes to the development and implementation of innovative policies and procedures  that will ensure optimized compliance with minimized risk. 
• Provides guidance to USMA on Patient Safety processes and requirements.
• Ensures USMA compliance with Pharmacovigilance (PV) Standard Operating Procedures and Working Practices
• Partners with the GDD risk management team and overall Patient Safety organization to work collaboratively towards addressing evolving needs and provide innovative solutions to balance the PV requirements of the Patient Safety organization with the business needs of USMA. 
• Strategically partners with Global Patient Safety, RA, US Medical and Global development, and other functions to ensure that Global and US Risk Management strategies are aligned. 
• Represent USMA requirements for any Patient Safety system enhancements 
• Takes the lead on any Patient Safety related compliance activities (e.g., audits and remediation). 
• Partners with medical, contracts and Patient Safety organization to resolve questions and requests for changes in template safety reporting language from institutions. 
• Serves as the US MAP Medical Governance Lead (MGL) as single point of contact interacting with MAP governance representing US voice, suggesting process and system improvements, and reporting back to US key messages. 
• Collaborates with key MAP stakeholders to ensure process alignment, assists in audits, metrics, and maintains oversight of US MAP program. 
• Partners with clinical team and other line functions to ensure successful implementation of MAP programs from onset until product launch 
• Serve as the MAP data steward by partnering with the clinical team to ensure system data is accurate and updated in a timely manner 
• Ensures cross collaboration with other team members to develop reports and metrics for monitoring medical activities for compliance, including development and implementation of risk management plans. 
• Oversees monitoring on predefined areas of business risk or ensure business conducts monitoring of its own business activities. 
• Proactively identifies potential gaps or risk areas related to quality and compliance regulations, guidelines, and trends affecting Novartis, and supports implementation of improvement initiatives. 
• Lead innovative solutions and communications that enhance compliance awareness across the organization. 

Essential Requirements:

• Minimum of 7 years in drug development in a major pharmaceutical company including 5 years in safety at an operational or medical position preferred. 
• Experience in clinical trial management, drug development, regulatory requirements, scientific methodology and/or broad understanding of Medical Affairs business functions required.  
• Clear understanding of GCP regulations and knowledge of international and FDA regulations, PhRMA cod