Head of Medical Affairs Quality System

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Date: Feb 12, 2019

Location: Anderlecht, Brussels, BE

Head of Medical Affairs Quality System

JOB SUMMARY

This function :

  • Ensures the existence of an efficient and compliant medical affairs quality system
  • Owns the medical affairs quality system;
  • Ensures monitoring of compliance and performance of the medical affairs quality system;
  • Ensures the mapping of the different medical affairs roles across the organization: anchor roles and associated individuals, linked to competencies and training curricula;
  • Ensures the maintenance of the process improvement projects in the Medical Affairs Practice
  • Ensures implementation of the medical affairs training strategy
  • Ensures ongoing external benchmarking (organizational design, efficiency etc.)

     

MAJOR ACCOUNTABILITIES

Lead, manage and develop the Medical Affairs Quality System team

Accountable for ensuring tools (e.g. MA process map) and processes (e.g. gap analysis) are in place to identify, assess impact of organizational changes

Accountable to oversee the MA Q System;

Accountable for ensuring MA Q system non-compliance are tracked, mitigated and resolved;

Accountable for ensuring the maintenance and the evolution of the audit/inspection readiness package.

Accountable for ensuring MA internal (compliance and performance) metrics  and benchmark are collected, analyzed and shared with the PS management as needed;

Build and maintain efficient collaboration with internal and external stakeholders

Additional roles:

Risk to Value Ambassador for Medical Affairs:

  • Member of the Risk to Value table
  • Coordinate the identification of new Enterprise Risks within the organization and ensure the record of the risks is maintained and kept up-to-date;
  • Coordinate the review of the risks mitigation actions and ensure the record is kept up-to-date;
  • Coordinate the review periodic of the enterprise risks owned by Medical Affairs and communicate the outcome to the Enterprise Risk Management Team

     

    Functional Data Privacy Officer:

  • Communicate the data protection functional role within his/her organization;
  • Become familiar with key data privacy principles and obligations, in particular the rules of the GDPR;
  • Coordinate the identification of personal data processing activities within his/her organization and ensure that the record of these activities is maintained in UCB’s data protection registry  (electronic Data Privacy Register);
  • Assist in the completion of Data Privacy Impact Assessment forms (DPIA) for functional data  processing likely to exceed pre-defined risk thresholds; and
  • Provide data privacy advice to business owners, as appropriate

EDUCATION & QUALIFICATION

10 years of pharmaceutical industry experience in clinical development/safety/medical or quality management position.

COMPETENCIES

Functional:

Successful partnering: Leverages and maximizes the diversity of MA community to establish and maintain trusted internal and external partnerships to achieve results and improve patient value through discussion and influence

  • Directs and drives strategies for new partnerships, shaping the development of sustained stakeholder relationships
  • Leads an inclusive and connected MA culture that creates and sustains patient value activities for UCB
  • Is recognized as a role model by internal and external partners for generating successful networks and fostering the value of MA across the organization
  • Builds a culture of transparency and respect around negotiating and agreeing mutually beneficial strategies and approaches with a diverse workforce that steps outside tradition and delivers benefits to all parties

Medical Governance: Works collaboratively to ensure the highest healthcare principles and standards are upheld, while creating agile frameworks and programs to deliver results that maximize patient value

  • Inspires a culture focused on the highest standards
  • Is recognized as a visionary leader driving and shaping current and future capabilities
  • Advises and influences senior management on critical governance decisions
  • Creates a culture that encourages colleagues to seek out opportunities to improve and streamline processes and procedures
  • Drives overall organizational capability in program/project management, focused on agility, sustainability, efficiency and measurable results in all relevant areas of the business
  • Champions a culture that encourages learning and experimentation with digital and technological solutions

Risk Management: ‘Anticipates, manages and escalates risks associated with our Medical Affairs quality system to protect scientific integrity

  • Champions a best in class MAQ system, through benchmarking across best practices in the industry

Shared:

Gathering and interpreting information. From ‘noise to signal’

Seeks deep understanding of stakeholders’/patients’ needs, motivations and behaviors, and translates them into insights to create value for patients and UCB.

Delivering impactful results. From ‘task to value’

Takes initiatives and works towards delivering results; Challenges self and others on value creation; Takes courageous decisions and balanced risks to create value for patients and UCB

  • Creates and fosters a culture which inspires the setting and attainment of ambitious value-focused targets
  • Fosters a dynamic and flexible approach to ensure that opportunities are exploited and risks managed in a way that protects and builds value
  • Models sound decision making and challenges others to always justify their decisions and actions against value creation

Thinking holistically. Connecting ‘internally and externally’

Understands the impact of own actions on other areas of the business; Looks for synergies inside and outside the organization to create value for UCB and patients.

  • Drives organizational collaboration internally and externally to create value for UCB and the patient
  • Acts as an inspirational role model to encourage creative collaboration across traditional boundaries to create value
    Combines experience and expertise in own field with a deep understanding of the industry and awareness of future trends to drive forward-thinking and develop long-term perspectives within the organization

Learning through experience. ‘Space with consistency’

Demonstrates curiosity and learns from the experience of success and failure; Proactively shares knowledge with others in order to affect continuous improvement.

  • Fosters a culture and mindset of learning from successes and failures
  • Creates an agile and open environment across multiple functions to encourage intellectual curiosity and innovation
    Is a role model for personal reflection and growth, sharing own experiences and journey to encourage others to develop themselves and strive for excellence
  • Creates a culture that provides space for innovation while ensuring strategic consistency

Working together. ‘Helpfulness and generosity’

Develops trustful relationships with internal and external stakeholders to accelerate business achievements; Encourages and leverages diversity to improve outcomes.

  • Coaches colleagues and teams on building trustful relationships with both internal and external stakeholders
  • Shapes and drives new partnerships using a variety of internal and external networks
  • Demonstrates own value of diverse thinking by actively seeking out input from non-traditional sources inside and outside the organization
  • Fosters a climate of inclusion, where diversity is valued and integrated in order to develop plans and solutions

Championing Change. ‘Agility and resilience’

  • Seeks new opportunities to create value for patients and UCB; Supports the implementation and acceptance of change across the organization

  • Engages and empowers others to embrace change by connecting the need for change to the long term vision
  • Anticipates and pursues new business opportunities in a changing environment
  • Challenges current working practices and business approaches in order to adapt to continuous changing business environments
  • Encourages and empowers others to change, and models resilience and agility during periods of change

Leading others. ‘Translates the vision into strategies’

Inspires, motivates, influences and coaches others to create value for patients and UCB; Creates a culture of accountability that provides space for colleagues to contribute to their full potential.

  • Communicates the vision and sense of purpose with enthusiasm, and ensures strategic priorities are understood and acted upon
  • Provides coaching and support to team and colleagues to encourage learning and development
  • Shows trust and provides learning opportunities to reports through delegation and opportunity for participation in new and stretching assignments
  • Accurately assesses each person’s strengths and uses them to get the best out of him or her
  • Motivates and influences a wide range of colleagues including direct reports, team members and project members
  • Hires the best people from inside or outside the organization


Job Segment: Medical, Quality Manager, Pharmaceutical, Inspector, Healthcare, Quality, Science

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