Associate Director of IT, Validated Business Systems
Viridian Therapeutics, Inc
Location
Waltham, MA | United States
Job description
At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.
Summary
Viridian has an exciting new opportunity to join our growing IT team as an Associate Director of Validated Business Systems. In this role you will plan, implement, manage, administer, and support key, validated, business application software. This includes all global validated applications across the Clinical Development, Clinical Operations, Biostats, Regulatory, Drug Safety, and Pharmacovigilance business units. You will also lead the identification and implementation of new validated software in these areas to support business growth.
Responsibilities - Collaborate with IT Leadership in the planning and implementation of validated Business Applications and Systems.
- Foster collaborative partnerships with business units to understand their short- and long-term strategic vision.
- Work closely with key stakeholders to understand business needs and translate them into IT requirements.
- Ensuring day to day operational excellence: this includes user management, troubleshooting problems, training, and handling change requests.
- Maintaining responsibility for the accuracy of system documentation, including User Requirement Specifications, Detail Design Specification, Configuration Specifications, Test Plans, and Summary Reports.
- Partnering with the Validation team to ensure that applicable applications are implemented and maintained in accordance with regulatory requirements, industry best practices and SOPs.
- Assist IT Leadership in the planning, managing, and maintaining of IT budget for technology projects, as well as ongoing licenses and support/maintenance contracts for the Application portfolio.
- Work collaboratively with System Owners to prioritize change control requests and ensure their timely completion.
- Provide technical support and troubleshooting of Validated Applications and Systems.
- Create and maintain documentation for application configurations, services, network mapping, processes, security, and compliance configurations.
- Manage relationships with third party vendors and ensure that external systems and services meet compliance and quality standards.
- Participate and help develop, implement, and maintain policies, procedures, and associated training plans for the administration and usage of Validated Applications and Systems.
- Additional duties and responsibilities as required.
Requirements
• A BS/BA in Information Technology or related field.
• 7+ years of experience leading Validated Applications Management in a Biotech or pharmaceutical company.
• Proven track record of successfully implementing Validated Applications.
• Experience working with Veeva Vault, Medidata Rave EDC, SAS and similar systems a plus.
• Ability to manage multiple projects simultaneously, manage conflicting priorities, and be flexible when priorities change.
• Experienced in managing project budgets, plans, requirements, and potential gaps.
• Significant experience managing vendors, MSPs, and direct reports.
• Brings attention to detail coupled with creative thinking to work through obstacles.
• Experience working with all levels of management and consulting with key business stakeholders.
• An 'always learning' approach - willing to test out new ways of working and thinking.
• An ability to influence for greater outcomes.
• Independent thinker with a strategic mindset, sound business judgment and exceptional IT analytical skills.
• Demonstrated ability to lead others through matrix to deliver outstanding results.
• Ability to strategically translate customer needs into executable action plans.
• Excellent interpersonal, communication, and presentation skills with the ability to interface seamlessly with other parts of the organization.
• Active listener, low-ego team player mentality, and a willingness to always go the extra mile.
This position is based in our Waltham, MA headquarters. Work from home, as needed, allowed, but onsite support is required with up to 10% travel.
Viridian offers a comprehensive benefits package including:
• Remote work with technology tools and infrastructure
• C ompetitive pay and stock options for all employees
• Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
• Company paid insurance programs
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various mental, financial, and proactive physical health programs covered by Viridian
• Free parking at our Waltham, MA site
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.
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