AD, Program Management - Vendor Onboarding

Key Responsibilities:

• Lead USMA TPQs as the subject matter expert (SME) responsible for the delivery of quality, timely, and cost-effective solutions for ESPs in adherence with Novartis SOPs, working practices and Global Procurement Guidelines.
• Drive the TPQ process from nomination to onboarding with ESPs and research collaborators
• Coordinate and lead internal TPQ meetings with internal SMEs and ESPs
• Manage internal relationships with Vendor Partnerships & Governance (VPG), Procurement, and external partnerships with ESPs to ensure consistency in documentation, quality, and operations for the matrix team.
• Oversee USMA ESP management consistent with Global and local standards and guidance
• Responsible for the ongoing governance and maintenance of existing ESPs by working closely with US Quality and USMA Evidence Generation Excellence Team to address gaps, audits, etc.  
• Represents USMA in workstreams with VPG, Quality and ERC to improve TPQ process.
• Represents USMA in internal and external audits as they relate to third-party management and support correction actions (CAPAs), as required with Evidence Generation Excellence and Director oversight.
• Identify, mitigate/create awareness of compliance risks, including excellent audit documentation.
• Provide guidance and training related to Third parties’ qualifications and monitoring activities to USMA Business Owners.
• Work in collaboration with QA to assess the applicability of the TPQ to service categories, and ensure Third Party’s adherence to GxP, Novartis’ best practices and SOPs, and industry standards.
• Tactical planning: Partners to lead the process of developing tactical plans aligned to strategies and priorities to actively seek to create next generation Third-Party qualification using technology/process improvement. Supports innovative initiatives to ensure the workload is prepared to successfully respond to the changing needs and requirements of our business partners.
• Secondary responsibilities may include negotiating and finalizing various ad hoc USMA research contracting types including, but not limited to statements of work, confidential disclosure agreements, assignments, amendments and budgets independently.
• Excellence in Business Solutions execution: Coordinates/tracks vendor onboarding metrics, scope driven milestones and overall VOB and business solutions progress. Provides program management support for selected tactics based on complexity and relevance and to harmonize and integrate with USMA BOs for required deliverables. Continuously assessing overall process to identify enhancement opportunities and improve strategic and tactical plans.
• Stakeholder management & communications: Engages with myriad stakeholders within USMA and across the global organization to ensure the delivery of quality, timely and cost-effective external resources to support USMA strategies.
• Knowledge management: US laws and regulations, including, but not limited to: Anti-kickback, HIPAA,  Sunshine, Anti-trust, etc.  Full understanding of contract language regarding US Pharma regulations to GxP, quality addenda, information security controls, financials with specific knowledge of Phase 1-IV, Registries, and IIT studies with secondary knowledge, including, but not limited to, research collaborations, sponsorships; implementation science; Real Word Evidence; HEOR; Data licensing that may shift based on evolving business needs.

Essential Requirements:

• Minimum 8 years of pharmaceutical industry experience and 8 years’ experience working with external service providers, healthcare organizations and academic medical centers.
• BA/BS is required. An advanced legal or business degree is preferred or the equivalent of the job, operational experience of 8 plus years.
• Detailed understanding of and experience with scopes of work associated with the clinical and non-interventional rials, HEOR/RWE and other Medical Affairs activities.
• Detailed understanding and experience negotiating external service provider terms and conditions
• Demonstrated ability to be successful in an agile Flexible Resource Model Team with the ability to master secondary skill set to flex to business goals.
• Solid financial understanding (of cost drivers for research programs, clinical trials and vendor outsourcing models) as it relates to contracts and cost reductions.
• Excellent written and oral communications skills & strong presentation skills, with an ability to make professional and credible first impressions with internal and external customers.
• Strong problem-solving and negotiation skills with demonstrated willingness to make decisions and to take responsibility.
• High degree of organizational, analytical, and team management and leadership skills.
• Strong cross-functional and proven collaboration skills with external and internal stakeholders.

Novartis Compensation Summary:

The salary for this position is expected to range between $132,300 and $245,700 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