Medical Affairs Business Implementation Lead

ob Description

We are seeking a dynamic and experienced Medical Affairs Business Implementation Lead to drive the execution of strategic initiatives, with a focus on digital transformation projects and validated systems. This role serves as a critical liaison between Medical Affairs business units and IT, ensuring seamless integration of technology solutions, including GxP-compliant systems, to enhance operational efficiency and support healthcare professionals (HCPs). The ideal candidate will bring expertise in Medical Affairs, project management, and digital tools to deliver innovative, compliant solutions that align with organizational goals.

Key Responsibilities

• Strategic Implementation: Support the planning, execution, and delivery of Medical Affairs projects, with a focus on digital transformation initiatives and validated systems that enhance business processes and HCP engagement.
• Cross-Functional Collaboration: Act as the liaison between Medical Affairs business units and IT teams to translate business needs into technical requirements, ensuring alignment on project goals and compliance with GxP standards.
• Digital Transformation: Oversee the implementation of digital tools and platforms, including Veeva Vault, VeevaLink, Veeva CRM, Quello, and Sci Max, ensuring integration with GxP systems and adherence to validation requirements.
• Validated Systems Implementation: Manage the deployment of GxP-compliant systems, ensuring proper validation processes (e.g., IQ/OQ/PQ) and compliance with regulatory standards.
• Portal and Website Development: Drive the creation and optimization of portals and websites tailored for HCPs, ensuring user-friendly interfaces, regulatory compliance, and integration with validated systems.
• Project Management: Develop and manage project plans, timelines, budgets, and resources to ensure on-time, high-quality delivery of initiatives, including those involving validated systems.
• Stakeholder Engagement: Collaborate with internal stakeholders (e.g., Medical Affairs, IT, Quality Assurance, Compliance, and Commercial teams) and external partners to align on project objectives and deliverables.
• Process Optimization: Identify opportunities to improve Medical Affairs processes through technology, data analytics, and validated systems.
• Compliance and Quality: Ensure all initiatives, including GxP systems, adhere to regulatory, compliance, and data privacy requirements within the pharmaceutical and healthcare industry.

Qualifications

Experience:

• 6-10 years of experience in Medical Affairs and project management within the pharmaceutical or biotech industry.
• Proven track record in leading digital transformation projects, with hands-on experience implementing tools such as Veeva Vault, VeevaLink, Veeva CRM, Quello, or Sci Max.
• Demonstrated experience working with GxP systems and implementing validated systems, including knowledge of validation processes and regulatory requirements
• Experience in developing or managing portals and websites for HCPs is highly desirable.

Skills:

• Strong understanding of Medical Affairs operations and the ability to bridge communication between business units and IT.
• Expertise in implementing and managing GxP-compliant systems, ensuring validation and regulatory compliance.
• Exceptional project management skills, with proficiency in methodologies such as Agile or Waterfall.
• Familiarity with regulatory and compliance requirements in the pharmaceutical industry, including GxP and data integrity standards.
• Excellent communication, leadership, and stakeholder management skills.
• Ability to manage multiple projects simultaneously in a fast-paced environment.