Clinical Medical Regulatory (CMR) Director

Novo Nordisk US

Novo Nordisk US

Legal
Lisbon, Portugal
Posted on Dec 2, 2024

Are you looking for an opportunity where you can utilize your leadership skills and medical expertise? Are you passionate about the world of medical affairs, clinical operations and regulatory affairs? Are you highly motivated by being able to make a difference to improving patients’ lives?

If so, you should continue reading and apply today!

The role is based in Lisbon, Portugal.

The position

As a Clinical Medical Regulatory (CMR) Director, you will be responsible for ensuring strong and forward-looking strategic plans and operational excellence for the CMR department, aligned with Novo Nordisk Portugal's overall commercial ambitions and priorities. You will drive value creation from a clinical, medical, regulatory, pharmacovigilance, and quality perspective while managing challenges, a regulated environment, and transformational change. Additionally, you will build a strong network and foster partnerships with key external stakeholders.

Your main accountabilities will be:

  • Drive planning and effective implementation of local CMR strategy, as integral part of portfolio and brand strategies and plans, in line with overall Novo Nordisk Portugal strategic ambitions and priorities, with high quality.

  • Membership and active contribution in the Portuguese Management team, ensuring enterprise leadership by effectively leading cross-functional collaboration.

  • Drive and ensure operational excellence in clinical, medical, regulatory, safety and quality operations of the company in full compliance with corporate and legal requirements to support new business opportunities and strategic objectives considering short, medium, and long-term local business needs.

  • Lead, inspire, coach develop and manage CMR team to maximize their full potential. Plan and develop CMR organisational setup, capabilities, and people in line with current and future business needs.

  • Drive strategic partnerships and engage with key stakeholders (KOLs, medical societies, identified key institutions in HC sector, and other institutions as relevant) to position Novo Nordisk as a preferred partner to unlock business opportunities and partner for better care.

  • Establishment and execution of international clinical trials in the country, ensuring business alignment. Ensure excellence in clinical trials execution in line with company policies, procedures, and ICH GSP requirements.

Qualifications

As Clinical Medical Regulatory (CMR) Director, you need to have a MD degree, or PhD in scientific majors. To be successful in this role, you should have:

  • A minimum of 5 years of people management experience within a pharmaceutical company, preferably in a Medical Director or Medical Manager position.

  • Fluency in both English and Portuguese.

  • Experience in cardiometabolic diseases will be a plus.

  • International experience in medical affairs, clinical and regulatory perspectives is highly desirable.

About The Department

The Clinical, Medical and Regulatory (CMR) department in Lisbon, Portugal, is one of the most diverse and collaborative groups within the organization. From health-care provider interactions and developing and implementing regulatory strategies, providing medical education, collecting data to support real world experience and support new product development through their life cycle. It provides clinical development, regulatory compliance, and it is responsible for medical support of marketed and non-marketed products of high quality.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact

Please click on "apply now" to submit your resume in English.

Deadline

Apply before 14th of December 2024

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.