Principal Analyst, Clinical Operations/Medical Writing

Role Summary

Principal Analyst, Clinical Operations/Medical Writing. The Business Engagement & Technology Principal Analyst will be a technical resource in ensuring delivery and support of COTS and a wide range of custom solutions in support of business partners, focusing on Clinical Operations and Medical Writing. Partner with business leadership to deliver capabilities and execute on a roadmap that aligns with business strategy, while maintaining reliable, scalable and compliant systems.

Responsibilities

• Become a trusted partner of the business leaders within their remit
• Understand needs and vision, and deliver technology solutions to support and enable goals and objectives
• Provide insights on how technology can improve business processes to enable operating efficiencies and support business goals
• Refine and execute the technology strategy by evaluating, selecting, implementing, and maintaining technology solutions
• Develop and maintain a long-term lifecycle plan for ongoing maintenance and management of systems
• Manage relationships with strategic software vendors and service providers
• Collaborate with DTE Compliance, Internal Audit, and Quality Assurance to ensure regulatory compliance and lifecycle/change management requirements
• Serve as a liaison between GMDA and Data, Technology & Engineering to ensure strategic alignment
• Apply Agile, Lean, and design thinking methodologies to optimize solution delivery
• Translate complex data into actionable insights and compelling business narratives
• Monitor emerging technologies and trends to inform GMDA’s digital strategy
• Drive change enablement and foster a culture of agility and continuous improvement

Qualifications

• In-depth knowledge in project management, business analysis, solution design, delivery, and testing
• Experience building partnerships with business stakeholders and aligning around recommendations
• Strong understanding of Clinical Operations/Medical Writing processes and regulatory environments
• Expertise in data analytics tools (Tableau, Power BI, SQL) and enterprise platforms in Clinical Operations (Veeva, Suvoda, Salesforce)
• Understanding of GMDA functions including clinical development, regulatory affairs, and medical affairs
• Proven track record of on-time delivery for large, complex projects with global stakeholders
• Ability to manage own workload with minimal direction
• Strong written and verbal communication skills; ability to present complex information clearly to technical and non-technical audiences
• Analytical, quantitative, problem-solving, and prioritization skills
• Strong system lifecycle expertise
• Experience running IT managed services or outsourced/offshore teams
• Excellent stakeholder engagement and communication skills
• MS Office proficiency (Project, Visio, Excel, PowerPoint)
• Experience with Agile methodology
• Ability to influence strategic decisions and drive alignment across diverse teams

Education

• Bachelor’s degree in Information Technology, Business Administration, Life Sciences, or related field; advanced degree preferred
• Minimum 8 years of experience in business engagement, technology strategy, or data analytics in pharma/biotech
• PMP or equivalent project management certification preferred
• Experience with AI/ML applications and digital transformation initiatives is a plus