Senior Director, Global Clinical Operations and Medical Writing Technology
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Overview
Job Description
Job Description
General Summary:
The Senior Director, GlobalClinical Operations and Medical WritingTechnology will lead a team responsible for planning, architecture, design, development, support,maintenanceand future roadmaps for systems supportingclinical operations and medical writingteams at Vertex. The incumbent will collaborate with senior leaders and other key stakeholders across these areas of the business, as well as peers across the Data, Technology and Engineering (DTE) organization, to identify, prioritize, design and deliverdigital and Artificial Intelligence (AI)solutions in support of their goals and objectives.
Key Duties and Responsibilities:
Partner with business stakeholders acrossGlobal Clinical Operations and Medical Writingteams to manage and prioritize thedigital and AItechnology portfolio and continually build the future roadmap
Build and strengthen relationships with key stakeholders - become a trusted partner and have an ongoing, significant impact towards meeting strategic business goals
Present ideas and forward-looking plans to, and engage directly with, cross-functional senior leaders on regular basis
Develop multi-year leadership-driven technology roadmaps delivering valued outcomes
Direct and lead a group of5Vertex team members, plus a managed services team of support engineers, administrators, and analysts
Oversee a portfolio of projects, programs,releasesand system enhancements, assuring quality and timeliness of delivery whileremainingwithinallocatedbudget limits
Proactively offer innovativenew tools/technologiesfor consideration, AIsolution ideas, and potential business process improvements in pursuit of driving efficiencies and meeting business needs
Enhance and improve internal processes and procedures related to demand management, resource management, project delivery, platformreleasesand ongoing operational support
Manage relationships with our strategic software vendors and service providers
Provide day-to-day support and maintenance for business-critical applications such asVeevaVaultClinical Trial Management System (CTMS), VeevaElectronic Trial Master File (eTMF), andElluminateElectronic Data Capture (EDC)platform,ensuringmaximumuptime, high performance, and excellent customer service
Work closely with Information Security and Quality Assurance groups as needed to ensure compliance withGxPregulations, as well as our DTE system lifecycle and change management requirements
Knowledge and Skills:
Direct experience with biotechnology and/or pharmaceutical systems, particularly in the areas ofclinical operations and medical writing
Hands-onexpertisewith identifying AI opportunities, deployingAgentic/Gen AIsolutions, andleading/supportingAI focusedorganizational change management and trainingfor business partners
In-depth knowledge of the biotech industry, including specific regulations such as 21 CFR Part 11 and Good Clinical Practices (or otherGxPareas)
Program/ project management, demand management, resourcemanagementand system life cycleexpertise
Strong communication, interpersonal and collaborative skills
Solid analytical and problem-solving abilities
Excellent verbal, written, and presentation skills to influence technical and non-technical audiences
Education and Experience:
Bachelor’s degree and 10+ years relevant work experience
Biotech or pharmaceutical industry experience
Experience managing implementation partners and managed services/ offshore teams
Deep experience with enterprise applications and SaaS implementations, upgrades,enhancementsand operational support procedures
In-depth experience in design, development, and deployment of technology solutions using agile software development practices
ITfinancial managementexperience, managing budgets and forecasts across operational expenses and new investments
Pay Range:
$228,000 - $342,000Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site EligibleFlex 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 select2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s 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 person's 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 ApplicationAssistance@vrtx.com
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