Associate Director - Safety Contract and Supplier Compliance

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Position

Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works (SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR Organization. Additional responsibilities include: Implementation of agreements on behalf of NNI in close coordination with CMR stakeholders, Procurement, and Legal. Managing internal and external strategic collaborations to optimize alliance performance by building relationships, developing and maintaining strong communication channels. and serving as a point of contact between CMR stakeholders and vendors. Driving strategic partnerships in accordance with relevant regulations and policies- Good Clinical Practice (GCP), ICH guidelines, Sunshine Reporting, federal regulations, and within defined budgeting guidance. Collaborating with cross-functional teams to ensure contractual compliance and driving continuous improvement. Works closely with suppliers to complete supplier setups, establish governances, conduct negotiations and ensure applicable NNI business practices, policies or guidelines are followed.

Relationships

This role works cross functionally with leaders within CMR, Legal, Procurement, Compliance, Privacy and other key internal stakeholders. In the execution of specific projects, the Associate Director, will be accountable for managing relationships with internal stakeholders and external partners relevant to the planning and execution of CMR initiatives while actively participating in multiple internal cross-functional teams to ensure the effective delivery of all functional and departmental milestones.

Essential Functions

• Drives CMR strategy for contract and budget negotiations through understanding and tactics to develop, execute and deliver clinical studies/programs on time with a focus on budget, compliance and quality. Leads strong and effective communication to global and local stakeholders to ensure consistency across CMR
• Leads a team of contract managers and specialists; ensures team is up to date on current industry practices around contracting and vendor compliance to contract requirements
• Builds efficient and effective relationships with 3rd parties by establishing governances, ensuring timely delivery of contracted deliverables, and making sure 3rd parties are following NNI training, policies and ethics, when applicable
• Tracks supplier performance using established metrics and collaborates with cross-functional teams to ensure rapid response to any quality concerns, audit findings, or vendor performance problems
• Develops and implements contract and negotiation polices, processes and best practices for CMR agreements, including but not limited to research partnerships and other collaboration agreements sponsorships, Investigator Sponsored Studies (ISS) and supplier service agreements
• Ensures compliance with government rules and regulations relating to the contractual and budgetary aspects of contracting with health care systems, health care professionals and organizations
• Maintains a deep understanding of CMR strategy and industry trends to drive informed decision-making with management buy-in and timely action for optimal customer results
• Understands governance of relevant contracts and acts as the primary point of contact with external partners to coordinate, communicate and document governance matters
• Strategically partner with CMR and NNI stakeholders on the planning and implementation of cross-functional programmatic initiatives
• Develop collaborative and positive relationships with constituents, senior leadership and external sponsors; engage with institutional partners to gain insights on partnership needs

Physical Requirements

Minimum lifting required. 10-20% overnight travel required.

Development of People

Supervisory

Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.

Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

• Bachelor of Science degree; Advanced degree preferred
• Minimum 10 years of experience with Supplier Management, Research Administration, Grant Operations, Grant Management, clinical trial management, or a similar research operations role
• Demonstrated ability to manage vendors – establish governances and milestones, manage meetings, track milestone progression, ensure trainings completed and vendor is adhering to contract requirements
• Experience working in a sponsored projects environment in an Academic / Medical or Research Institution
• Advanced experience in budget and contract negotiations with clear understanding/impact of contract and financial schedules, (i.e. cost benefit analysis, ROI, KPI, financial milestones and related payment schedules)
• Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and the application of those principles to trial design, planning & conduct of clinical trials
• Advanced capability in MS Excel, MS PowerPoint and MS Word required
• Excellent negotiation skills with the ability to understand, identify, and explain contractual risk
• Ability to think strategically and initiate strong and persuasive contractual arguments to support business policies and objectives
• Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions
• Excellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settings
• Demonstrated ability to collaborate with local and global stakeholders to design and execute analyses to support decision-making and planning
• Excellent skills in designing and implementing innovation/improvement initiatives, including the required change management

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.