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Senior Director, Medical and Regulatory Affairs

 
Requisition ID:  1469
Location: 

Montreal, Quebec, CA

Date:  Nov 19, 2020
 

 

We are looking for a qualified Senior Director, Medical and Regulatory Affairs to lead Medical and Regulatory Affairs team and join the Lundbeck Canada leadership team. The candidate will report to the Vice-President and General Manager of Lundbeck Canada, and indirectly to the head of global medical affairs.

The Senior Director, Medical and Regulatory Affairs is responsible for providing overall leadership, scientific expertise and strategic direction for the Medical and Regulatory team and overview quality assurance/GMP compliance activities. As a member of the leadership team, the Senior Director, Medical and Regulatory Affairs must anticipate future needs and opportunities to build a strong vision for the department, while keeping aligned with the Lundbeck’s Code of Conduct, local regulations and other requirements. He/she is expected to manage capacity, budget and performance for the teams of Medical Scientific Liaisons and Scientific Advisers, Pharmacovigilance and Medical Information, Regulatory Projects and Medical Communications.

 

Medical Affairs (35%)

  • Plan and drive effective medical affairs strategies that support business growth and high performance in Canada
  • Ensure that medical activities and supporting resources are aligned with the commercial objectives and prioritize the department’s activities within the existing and future product portfolio
  • Ensure cross functional collaboration with the market access and commercial operations teams, providing scientific expertise and strategic guidance for business planning; responsible for reviewing the scientific content of HTA submissions, promotional material and sales teams’ training.
  • Build and cultivate strong relationships with national opinion leaders and support the field activities of the Medical Science Liaison team
  • Ensure alignment of external partners with clinical development and medical activities
  • Overview adequate planning and execution of medical advisory boards and consultancy meetings with healthcare providers
  • Ensure proper communication of collected clinical insights and development of gap analyses and medical strategies for evidence generation, medical education and communication
  • Provide medical expertise to support the development of medical education content, ensuring its accuracy, objectivity and quality
  • Handle risk management issues and escalate to upper management for resolution when critical
  • Liaise with the headquarters’ Corporate Medical and Regulatory Affairs senior management, maximizing visibility for the department
  • Maximize opportunities for local research investments and partnerships; advocate for participation in early and late phase development programs of new compounds
  • Identify and network with Canadian investigators and research experts to achieve the best possible drug development outcome
  • Ensure that proper resources and systems are in place to support the Medical Information and Pharmacovigilance team
  • Ensure the Pharmacovigilance and Medical Information team members and processes are in compliance with corporate SOPs and codes of ethics as well as all other local requirements and regulations
     

Regulatory Affairs & Quality Assurance/GMP (30%)

  • Provide strategic regulatory and registration support, guidance and recommendations for early and later stage regulatory projects in Canada
  • Conduct strategic pre-submission regulatory and compliance reviews and guidance on all development projects in Canada; identify developmental issues, challenges and corresponding resolutions to ensure adequate regulatory compliance of submissions
  • Ensure quality assurance reviews and releases are conducted in respect of SOPs and regulations; ensure registrations and ATI submissions are transmitted to relevant Health Authorities and other stakeholders
  • Act as primary liaison with Health Canada senior management, TPD reviewers and external consultants
  • Act as senior moderator for all required regulatory meetings with Health Canada
  • Provide strategic support for Quality Assurance (QA) and GMP compliance for all marketed products while anticipating needs for development products.
  • Ensure timely application and renewal of the Drug Establishment License for all marketed products
  • Stay abreast of all regulatory requirements and changes affecting the commercialization of products in the country

 

Corporate & Legal Affairs (5%)

  • Provide scientific advice and assistance regarding a variety of corporate matters, defending company’s position and interests; collaborate with legal experts on patent registration and litigation
  • Provide expertise and advice for business development opportunities, corporate communications and incident reporting
  • Act as an official medical spoke person for the affiliates
  • Enhance scientific network with academia, associations and other relevant groups or stakeholders in the country

 

Lundbeck Canada Leadership Team and Management Responsibilities (30%)

  • As a member of the Lundbeck Canada Leadership Team, demonstrate its commitment to the establishment, implementation, assessment and continual improvement of the management practices and processes as well as the embodiment and rooting of Lundbeck principles, values as well as compliance and ethic rules.
  • Contribute to the strategic long-term planning of the organization.
  • Provide department leadership, coaching and direction, ensuring the team member(s) get adequate training to perform their tasks and develop and maintain their capabilities and expertise.
  • Nurture a culture of high performance, engagement and compliance, with a strong alignment on results and critical behaviors through the performance management process, ongoing assessment and guidance; act as role model in the visible promulgation of these values and expectations; ensure executional excellence and monitor employees’ performance impact.
  • With the collaboration of the HR Business Partner, develop the local organization by identifying and growing talent to achieve the vision, planning strong succession when possible.
  • Embody managerial courage, consistently applying and coaching honest communication and team/cross-functional collaboration.
  • Ensure proper planning and follow up on capacity and activity budget for all medical teams.

 

 

Position Qualifications:

  • Medical Degree
  • A minimum of 10 years of experience in managing medical affairs and clinical research activities in the Canadian pharmaceutical industry
  • Proven track record in successfully managing large teams 
  • Scientific expertise in neuroscience 
  • Excellent knowledge of the Canadian regulations and extensive experience in managing regulatory affairs projects and interacting directly with Health Canada
  • Experience in the area of GMP compliance (QA/QC) working directly with Health Canada, including the HPFB Inspectorate, an asset
  • Experience in dealing with service providers and external consultants
  • Result-oriented with strong critical thinking and analytical and organizational skills
  • Excellent knowledge of oral and written English; ability to communicate in French strongly preferred
  • Excellent computer

 

 

Working conditions

  • Normal Office conditions: Yes
  • Evening/Weekend commitments: Occasionally
  • % of travel required: 15%

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
 
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
 
Read more at www.lundbeck.com/global/about-us/progress-in-mind
 
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.