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Director, Business Systems
4 months ago
Description: Director, Med Affairs Business Systems & Governance
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
The Business Systems & Governance Lead (BSGL) oversees all internal and vendor-owned systems tailored for the Medical Affairs Delivery Unit (MA DU). This role is responsible for the comprehensive implementation and management of global cross-divisional systems supporting MA DU evidence generation activities, such as interventional studies, non-interventional studies, Investigator Initiated Studies (IIS), research collaborations, and Managed Access Programs. The BSGL drives the integration of digital health operations and ensures operational excellence within a governance framework, encouraging innovation while maintaining compliance and continuous improvement.
The BSGL formulates system/capabilities/solutions-related strategies and operational frameworks for the MA DU, aligning with Global Development (GD) and Medical Affairs (MAF) practices. Acting as the primary liaison for systems/capabilities/solutions requirements and data governance policies, this role collaborates with GD, MAF, Data Sciences, R&D Quality, and Legal departments to maintain an integrated governance strategy. This strategy ensures effective oversight and monitoring of MAF activities related to evidence generation, supporting systems in accordance with MAF objectives.
Additionally, the BSGL provides line management to Digital Health Managers/Specialists and the Operational Excellence and Compliance team, playing a crucial role in talent development and aligning team efforts with the strategic goals of the MA DU.
Major Duties & Responsibilities:
- System and Governance Oversight
- Ensure MA DU input in the strategies and product capability roadmap.
- Design and implement robust governance frameworks to support MA DU and MAF strategic objectives, enforce data protection laws and regulations, and ensure system integrity and security through regular audits and assessments in partnership with IT and Integrated Data Analytics & Reporting (IDAR).
- Collaborate with IT/IDAR to develop and maintain policies and procedures for system use, access control, and data handling.
- Strategic Planning, Partnership, and Collaboration
- Develop system metrics and KPIs aligned with MA DU and MAF strategic goals.
- Monitor system performance and user engagement, providing actionable insights to senior leadership.
- Serve as the primary liaison between MA DU and internal teams (GCO, MAF), addressing system gaps and risks through collaboration with IT and cybersecurity teams.
- Advocate for system needs and priorities in key corporate boards and initiatives.
- In partnership with IT/IDAR, identify new technologies and innovations to improve system capabilities and user experience.
- Develop business cases for system improvements and expansions, securing senior leadership buy-in.
- Cultivate relationships with external partners and vendors to improve system functionalities and services to support MA DU.
- Change Management and Implementation
- Own the development and implementation of change management plans for system updates and improvements.
- Ensure comprehensive communication strategies to inform stakeholders of upcoming changes.
- Design and deliver training programs to facilitate smooth adoption of new systems and features.
- Monitor user adoption rates and feedback, adjusting change management approaches as needed.
- Collaborate with Global Development and quality teams to develop and review SOPs for clinical systems and processes, addressing operational gaps to improve compliance and efficiency.
- Digital Health Operations and Operational Excellence
- Lead all aspects of the integration of digital health operations within the governance framework, ensuring efficient and compliant processes.
- Cultivate innovation in digital health solutions and operational processes, ensuring compliance and continuous improvement.
- Team Leadership and Development
- Provide line management to Digital Health Managers/Specialists and the Operational Excellence and Compliance team, including recruiting, coaching, and mentoring.
- Ensure staff development and alignment with the strategic goals of the MA DU.
Qualifications:
Required Qualifications:
- Education: Advanced degree in life sciences, data sciences, IT, or business management.
- Experience: Minimum 15 years in the industry, with at least 10 years in cross-functional international leadership roles.
Knowledge, Skills, and Abilities:
- Deep understanding of drug development processes with experience in clinical development.
- Knowledge of digital innovation, data analytics, machine learning, and AI.
- Experience in system deployment or equivalent.
- Demonstrated ability in project management and change management.
- Advanced organizational acumen with experience in cross-functional, global team settings.
- Strong interpersonal, problem-solving, and conflict resolution capabilities.
- Proficient negotiation, influence, and communication skills.
- Proven ability to synergize scientific and business stakeholders.
- Effective teamwork across multifaceted geographical locations and expertise in encouraging partnerships within a matrixed organization.
- Demonstrated history of talent development.
People Management Experience: Minimum of 5 years of experience in functionally leading teams, providing mentorship, and leadership.
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