Address
Form of workAbout 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
Drive and implement NAO Patient Safety strategy specific to creating, setting direction, team integration for Novo Nordisk (NN) Hub locations (India and Mexico). Resource planning and prioritizing department tasks to ensure optimal and flexible use of resources, monitor, and report affiliate support team's performance. Ensure efficient, open, and frequent interaction and communication with stakeholders. Maintain a network within different departments of Global Safety, Novo Nordisk Inc. (NNI) Patient Safety, and outside of Global Safety. Maintains alignment between all case processing units for NAO Patient Safety.
Relationships
Reports to the Executive Director, NAO Patient Safety with cross-functional working relationships within Medical, Regulatory, Marketing, QA, Legal and IT. This person will provide direct guidance to a team. This position works closely with counterparts in the Global Safety Departments, including Safety Operations, And Global Service Center.
Essential Functions
- Resource Planning and Performance Monitoring:
- Establish, maintain, and develop efficient processes for North America safety case handling in close collaboration with NAO PS Management, HQ departments and Safety Global Business Services (GS-GBS) to ensure compliance with regulatory requirements
- Ensure coordination of activities and perform resource planning for NNI case processing and NNCI affiliate processing
- Monitor performance, including regulatory compliance by applying relevant metrics and inform the Executive Director, NAO PS
- Monitor Internal workflow timelines by applying relevant metrics and ensure that department KPIs are met
- Ensure optimal and flexible use of resources in the group, including timely identification and resolution of resource gaps
- Secure cross-organizational collaboration with all relevant stakeholders daily and ensure the adoption of a global mindset
- Quality & Compliance:
- Ensure the department’s time and quality compliance concerning case handling on Novo Nordisk products and devices
- Ensure development and maintenance of departmental and functional procedures and processes related to the collection and reporting of safety data to ensure regulatory compliance
- Prepare, and participate in audits and Inspections
- Assure compliance with Novo Nordisk Quality system and business ethics
- People Management:
- Recruit staff and request staff in support of PS resource planning
- Develop, support, and coach for people management roles
- Ensure timely completion of tasks by project milestones
Physical Requirements
A certain amount of international travel is required for training purposes, collaboration, and/or management meetings with other departments in Denmark, Mexico, and India.
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
- A Bachelors degree required. An advanced degree is preferred (M.S., Pharm.D., Ph.D., M.D.)
- At least twelve years of experience is required, related to Scientific, Regulatory, Pharmaceutical and Medical areas, with at least five years of experience in the Patient Safety area preferred
- Supervisory management experience of at least five years is required
- Knowledge of international Pharmacovigilance legislation and guidelines
- Good knowledge of business processes, including IT systems (including databases and web solutions) required for the establishment of efficient handling of safety information
- Knowledge of GMP and GCP requirements, including GXP documentation
- Experience with working in international and diverse professional groups
- Excellent people leadership and interpersonal skills as well as professional authority
- Good communication skills
- Fluency in English, both written and spoken
- Ability to perform timely and effective performance management
- Demonstration of independence and initiative in decision-making that involves coordination with other internal and external stakeholders
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.
