Systems Engineer - Veeva Platform and Integrations

Manchester, NH
Permanent
Full-time

2 months ago
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About SequelSequel Med Tech is an emerging medical device company committed to revolutionizing patient care through innovative solutions. Our mission is to improve the lives of patients by developing cutting-edge medical technologies that address unmet needs in healthcare.Job OverviewThe Systems Engineer - Veeva Platform and Integrations is primarily responsible for working closely with Quality, Regulatory, Validation, and IT teams to provide strategic guidance, solution architecture, and implementation oversight for all IT solutions and projects deployed to these departments. Systems Engineer - Veeva Platform and Integrations will work with external vendors and business stakeholders to bring new systems on board and to operationalize existing systems in a steady state. This position will be responsible for maintaining the systems roadmap and budget for the Veeva and integrated Platforms. Systems Engineer - Veeva Platform and Integrations will develop and implement a good governance process to manage releases, enhancements and change control for all applications in the portfolio and contribute to the overall IT governance framework.Job Responsibilities and Essential Duties

Collaborate on the design and lead the implementation of proposed Enterprise Applications solutions across a group of specific business applications or technologies based on enterprise business strategy, business capabilities and business requirements
Lead the administration, configuration, and optimization of Veeva Vault PromoMats to support Sequel Med Tech’s Quality Management System (QMS).
Develop custom solutions and integrations to automate workflows, enhance system capabilities, and integrate with third-party applications.
Develop and maintain a strategic roadmap for the evolution of the quality management and business applications portfolio from current to future state in alignment with organizational goals and industry best practices.
Document all solution architecture design and analysis work.
Manage and implement all required changes for applications following change control best practices.
Collaborate with Quality, Regulatory, Validation, IT teams, other G&A groups and Developers in the selection, design, implementation, and enhancement of Quality and business applications.
Work with vendors and external partners to implement new modules, resolve issues, and optimize system performance.
Serve as the primary liaison between the different G&A Groups, Quality, Regulatory, Commercial, Validation, HR, IT, and other business units, ensuring clear communication and understanding of priorities and needs.
Develop and align policies, standards, and procedures related to finance and business applications.
Ensure alignment with industry-specific regulations and maintain compliance with regulations such as CFR Part 11.
Oversee the design, development, testing, and deployment of systems and solutions, ensuring alignment with stakeholder requirements, best practices, and industry standards.
Manage the project budget, timeline, resources, risks, and issues, ensuring timely resolution and escalation.
Coordinate with IT and external vendors to ensure seamless integration and adherence to compliance standards.
Establish and maintain strong relationships with vendors, ensuring that products and services meet quality and performance expectations.
Provide regular reports and insights on application performance, usage, and benefits realization to business partners and leadership.
Analyze and recommend improvements to existing systems and processes to drive efficiency and effectiveness.

Minimum Requirements

Bachelor’s degree in IT, Business, or a related field preferred.
5+ years of experience managing Veeva Vault applications (PromoMats, or similar) preferably in a biotech/pharmaceutical/Med Device environment. Experience with Quality Docs, Training, MedComms, Clinical, RIM Vaults a plus.
Experience working with the Veeva to develop custom functionalities, automate processes, and extend Veeva Vault capabilities.
Proven ability to manage system implementations, enhancements, and integrations in a regulated environment.
Experience with change management, release governance, and system lifecycle processes

Required Knowledge, Skills and Abilities

Proven ability to manage complex projects and lead cross-functional teams.
Strong understanding of Veeva Platform is required.
Strong understanding of GxP processes, Quality Management systems, and business application architecture.
Working knowledge of change management, GxPs, 21 CFR Part 11/Annex 11 and related regulations & guidance.
Thorough knowledge of relevant SOX compliance and regulatory standards.
Exceptional communication and relationship-building skills.
Project Management (e.g., PMP) or relevant technology certifications (e.g., Veeva Vault Admin Certification) is a plus.
Data Management and analysis experience is a plus.

Preferred Skills and Competencies:Administrative skills and knowledge of Veeva Vault PromoMatsand enterprise system integrations.Required Knowledge, Skills and AbilitiesSequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment 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, or local laws.Environmental/Safety/Physical Work Conditions

Ensures environmental consciousness and safe practices are exhibited in decisions.
Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
May work extended hours during peak business cycles.
Physical requirements such as lifting specific weights.
Some travelling is expected.

Sequel Med Tech