Principal Analyst, Clinical OperationsMedical Writing

Job Description

General Summary:

The Business Engagement & Technology Principal Analyst will be a technical resource in ensuring delivery and support of commercial-off-the-shelf (COTS) and a wide range of custom solutions in support of their business partners. The Business Engagement & Technology Principal Analyst will partner with business leadership to deliver capabilities and execute on a roadmap that align to support business strategy in Clinical Operations and Medical Writing . Additionally the Business Engagement & Technology Principal Analyst will maintain reliable scalable and compliant systems that easily meet business needs by efficient delivery and enhancements that provides opportunities for developing and implementing innovative solutions and integrations.

Key Duties and Responsibilities:

• Become a trusted partner of the business leaders within their remit
• Understand their needs and vision and deliver technology solutions to support and enable their goals and objectives
• Provide insights on how technology can improve business processes to enable operating efficiencies and support the achievement of business goals and objectives.
• Help refine and execute the technology strategy by leading the evaluation selection implementation and ongoing maintenance of technology solutions.
• Develop and maintain a long term life cycle plan for the ongoing maintenance and management of systems.
• Manage relationships with our strategic software vendors and service providers
• Work closely with DTE Compliance Internal Audit and Quality Assurance groups as needed to ensure compliance with all appropriate regulations as well as our DTE system lifecycle and change management requirements
• Serve as a liaison between GMDA and Data Technology & Engineering (DTE) 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 GMDAs digital strategy.
• Drive change enablement and foster a culture of agility and continuous improvement.
  
  

Knowledge and Skills:

• In-depth knowledge in the core disciplines of project management business analysis solution design delivery and testing
• Experienced in building productive partnerships with business stakeholders and aligning them around a recommendation/solution
• Strong understanding of the business (Clinical Operations/Medical Writing) processes and any appropriate regulatory environments
• Expertise in data analytics tools (e.g. Tableau Power BI SQL) and enterprise platforms in the Clinical Operations space (e.g. Veeva Suvoda Salesforce).
• Deep understanding of GMDA functions including clinical development regulatory affairs and medical affairs.
• Results oriented contributor with a proven track record of on-time project delivery for large complex projects with global stakeholders
• Able to manage own workload with minimal direction
• Very strong written and verbal communication skills and strong ability to present complex or sensitive information in a clear and concise manner to various technical and non-technical audiences
• Exceptional analytical quantitative problem-solving and prioritization skills
• Strong system life cycle expertise
• Good knowledge of running IT managed services or outsourced/ offshore teams
• Exceptional communication and stakeholder engagement skills.
• Very strong MS Office skills including MS Project & Visio Excel and PowerPoint experience
• Experience in Agile methodology
• Ability to influence strategic decisions and drive alignment across diverse teams.

Education and Experience:

• Bachelors degree in Information Technology Business Administration Life Sciences or related field; advanced degree preferred.
• Minimum of 8 years of experience in business engagement technology strategy or data analytics within the pharmaceutical or biotechnology industry.
• PMP or equivalent project management certification preferred.
• Experience with AI/ML applications and digital transformation initiatives is a plus.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at