Director, Evidence Generation & Compliance

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 code and other industry guidelines and regulations. 
• Strong leadership, project management, communication, presentation, and interpersonal skills required. 
• Proven organizational skills with demonstrated expertise in influencing across a matrix and in managing multiple priorities.  
• Ability to communicate effectively, manage issues, resolve conflicts, and mitigate risks 
• Experience in preparation of clinical safety assessments and regulatory reports/submissions involving safety information. 

Desirable Requirements:

• Experience of REMS/RMPs preferred.  

Novartis Compensation Summary:

The salary for this position is expected to range between $168,000 and $312,000 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.