Vp, Clinical Development, Medical, Regulatory - Mississauga, Canada - Novo Nordisk

Novo Nordisk

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Working at Novo Nordisk

At Novo Nordisk, your skills, dedication and ambitions help us change lives for the better for 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.

In exchange, we offer you an opportunity to work with extraordinary talents and benefit from a range of possibilities for professional and personal development.

Summary

The Vice President, Clinical Development, Medical & Regulatory (CDMR) provides overall leadership and management of the Medical Affairs, Regulatory and Clinical Development functions with the goal of maximizing the life cycle of Novo Nordisk products and pipeline projects: before, during, and after launch.

Major Accountabilities
Leadership

Provides general direction for the development, implementation and coordination of clinical development, medical affairs and regulatory plans
Provides general direction to CDMR Management related to departmental goals and priorities.
Fosters crossfunctional collaboration and facilitates communication within, and outside of CDMR. Provide expert level support and guidance crossfunctionally on issues related to CDMR functions, as appropriate
Manages the employees of the department, interviewing and hiring new employees, carrying out performance appraisals, directing the training and development of staff and carrying out disciplinary actions in coordination with CDMR Management Team
Maintains and champions quality mindset in all business processes within CDMR, and coordinates process improvement initiatives
Ensures full compliance to Novo Nordisk Quality system, Business Ethics and all other applicable rules and regulations
Creates and maintains a positive work environment where all employees can maximize their job satisfaction, potential and productivity
Be a promoter and incubator of talents for CDMR.

Executive Management

Acts as a member of the Executive Team developing, recommending and implementing strategies, and action plans to achieve the goals of the company
Participates in crossfunctional teams, as appropriate, developing, recommending and implementing short and longterm strategic goals for the company
Develops and manages departmental budget, monitoring progress throughout the year, reviewing and revising as appropriate
Liaises with other Executive Team members and parent company management staff to communicate information, resolve problems and identify corporate priorities
Participates in the general management of the company, attending Executive Team meetings and making strategic and policy decisions

Department Management

Directs the provision of technical training and information regarding medical and scientific issues to field sales and head office employees
Directs the provision of timely, relevant and accurate medical and product information to all classes of customers
Provide medical input to marketing plans, promotional campaigns, and new product launch platforms including the provision of medical input to the Brand Teams, product launch teams, LCM activities or other relevant bodies
Ensures that marketing materials and programs have been reviewed for medical content, regulatory requirements and ethical standards
Provides overall guidance and strategic input on the Medical Education activities and scientific educational efforts in support of sponsored scientific events and learning programs as appropriate
Maintains regular and frequent contact with key opinion leaders (KOLs) in diabetes, Obesity, and other relevant therapeutic areas. Ensure strategic plans in place for engaging and appropriately communicating with the top national and global KOLs
Direct collaboration between Canadian staff and counterparts within the Region and Global organizations
Provides strategic input to Canadian clinical programs from initial concept to finalization
Enhances the product development process by crossfunctional support of the development and implementation of market access programs and services, including pharmacoeconomics, outcomes research and disease state management programs
Provide strategic oversight to the process of internal submissions and evaluation of investigatorsponsored studies (ISS) in collaboration with key stakeholders within NN Canada and globally
Directs all product and service development process by ensuring the relevant reviews of clinical summaries and reports for medical content in support of submissions to Health Canada
Directs the regulatory approval process to meet or exceed industry standards
Maintains current knowledge or regulatory environment
Strategically supports the communication and dialogue with Health Canada in relation to the Canadian regulatory process and other relevant engagements
Maintains uptodate knowledge of functional area, health care industry and general management issues
Assesses and maintains medicolegal and ethi