The Opportunity:

The GxP Systems Administrator will be responsible for the day-to-day support and administration of application platforms that enable our Research & Development (R&D) functions. The ideal candidate will have hands-on experience administering and configuring GxP-compliant SaaS systems (particularly Veeva Vault), including basic security updates, object configuration, and lifecycle and workflow management, along with a strong understanding of regulatory requirements in a life sciences environment.

This individual will play a key role in handling user requests, provisioning accounts, troubleshooting issues, and supporting the implementation and maintenance of new GxP applications and systems. Strong technical skills, attention to detail, and the ability to communicate effectively across functional teams are essential for success in this role. As a member of the Information Sciences team, the GxP Systems Administrator will report directly to the Senior Manager, GxP Business Systems and collaborate closely with CSV, Quality, and other R&D stakeholders to ensure systems are effectively managed and remain in a validated state. Key responsibilities include:

• Administer and support GxP systems that enable R&D functions in compliance with applicable regulations and standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5).

• Manage user access for GxP (and occasional non-GxP) systems, including provisioning, modification, and deactivation of accounts per company procedures.

• Troubleshoot and resolve support requests and incidents related to GxP systems using ServiceNow, ensuring timely, accurate documentation and adherence to defined SLAs.

• Collaborate with cross-functional teams (e.g., Quality, Regulatory, Clinical, IT) to support business operations and ensure compliance.

• Perform routine system activities such as periodic user access reviews, audit trail reviews, and other steady-state tasks per company procedures and regulatory standards.

• Support the implementation and maintenance of new GxP systems, including validation activities and system documentation (e.g., specifications, user guides, administration procedures).

• Participate in change control, impact assessments, and release management for validated systems.

• Maintain a working understanding of applicable GxP regulations and guidelines (e.g., 21 CFR Part 11, Annex 11, GAMP 5) and ensure data integrity principles (ALCOA+) are applied in day-to-day system administration and operations.

Required Skills, Experience and Education:

• Bachelor’s degree with a minimum of 2 years experience in Information Technology/Computer Science supporting GxP-regulated environments, in pharma, life sciences or related industries.

• Veeva Vault Platform Administrator certification required (or ability to obtain within 6 months of hire), with demonstrated hands-on experience administering and configuring Veeva Vault applications (e.g., QualityDocs, QMS and RIM).

• Experience supporting or administering Veeva Vault systems.

• Basic understanding of GxP regulatory expectations and industry guidelines (e.g., GAMP 5, FDA, EU).

• Knowledge of user management, including security access controls, policies, and permissions.

• Experience providing system support preferably using ServiceNow, including troubleshooting and resolving user issues.

• Efficient time management, with the ability to support multiple systems simultaneously.

• Strong written and verbal communication skills and the ability to present complex information.

• Ability to work effectively in a dynamic and fast-paced environment.

• Experience with applications supporting life science research and development.

Preferred Skills:

• Direct experience administering and configuring Veeva Vault (Quality, RIMS), eTMF (Trial Interactive), DocuSign Part 11, ComplianceWire, and similar GxP systems.

• Working knowledge of Computer System Validation (CSV) principles and deliverables, Software Development Life Cycle (SDLC) processes, and 21 CFR Part 11 compliance, with applied experience in validation documentation and ensuring regulatory adherence.

• Familiarity with Active Directory and Azure Entra.

• Basic scripting or automation skills (e.g., Python, PowerShell) to support system efficiency.

• Experience collaborating with Quality and Regulatory teams within a GxP environment. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

The Associate Director, Global Commercialization Systems Enablement is responsible for coordinating and enabling Commercial and Medical Affairs global systems work across markets outside the United States. This role ensures that regional needs are clearly understood, refined, and effectively integrated into established global processes, including launch orchestration, compliance frameworks, software development lifecycle practices, and prioritization governance. For new market launches outside of the United States, this individual will lead the associated Commercial and Medical business systems workstreams, ensuring coordinated planning, readiness, and execution across regional IT teams, global Commercial and Medical solution teams, and enterprise technology teams.

The Associate Director adds value by clarifying requirements, identifying cross market commonalities, and reducing discovery work for global delivery teams such as Omnichannel Solutions, Data Solutions, Medical Affairs Solutions, and Field Solutions. The role supports seamless pull through of work into global intake and execution models, helping regional IT leads and enterprise partners operate more efficiently while maintaining alignment with global standards.

Partnering with IT, Information Security, Planning & Management, G&A Systems, R&D Systems, and other enterprise technology partners as needed, this leader helps ensure that solutions are compliant, scalable, and launch ready. This role helps scale global systems as commercialization activity expands across markets, indications, and products, by strengthening coordination, improving visibility, and supporting consistent execution without creating bottlenecks or slowing direct collaboration where it is most effective.

Global Enablement and Orchestration

• Lead the Commercial and Medical business systems workstream for Global Markets (outside of the United States), providing governance, coordination, and visibility across regional initiatives.

• Act as the interface between regional IT requests in Europe and Japan and the global Commercial and Medical Information Systems team as well as facilitating partnership with enterprise IT.

• For global systems, translate regional business needs into executable work in partnership with global solution teams.

• Shape and qualify ex US demand before it enters global intake forums.

Planning and Launch Readiness

• Drive planning, intake coordination, and launch preparation activities for ex US markets.

• Support sequencing and pull through of work into global systems and processes.

• Manage cross regional dependencies to reduce delays and ensure aligned execution.

• Enable coordinated planning and execution as additional markets, indications, and products are introduced.

Operating Model and Scalability

• Establish a repeatable and scalable operating model for global commercialization systems support.

• Enable regional IT teams to move quickly at the local level while maintaining global consistency and efficiency.

• Proactively manage coordination complexity and time zone challenges to support effective collaboration between regional teams and global solution leaders.

• Enhance global visibility into demand, priorities, and delivery readiness.

Cross Functional Partnership

• Drive action day to day with peers across Data Solutions, Field Solutions, Omnichannel Solutions, and Medical Affairs Solutions to support integrated execution.

• Proactively engage and align cross enterprise technology partners including IT, Information Security, Planning & Management, G&A Systems, and R&D Systems Teams to ensure integrated planning, risk management, compliance, and end to end solution readiness across global markets.

• Partner with enterprise stakeholders to ensure systems are compliant, secure, and operationally ready.

Required Skills, Experience and Education:

• Bachelor’s degree required (or equivalent).

• 8 plus years of experience in commercial systems, medical systems, IT business partnership, program management, or related disciplines.

• Experience supporting global or multi regional initiatives, preferably across Europe and Asia Pacific.

• Strong understanding of commercialization processes, launch readiness, and cross functional delivery models.

• Demonstrated ability to lead without direct authority in a highly matrixed global environment.

• Excellent stakeholder management, communication, and organizational skills.

• Proven ability to build trust and manage relationships across multiple functions.

• Proven ability to build structure in ambiguous or evolving operating environments.

• Strong understanding of Commercial systems and data sources (CRM, digital/website, secondary data, visualization platforms).

• Understanding of regional data privacy and compliance regulations and processes.

• Ability to manage a portfolio of projects, activities, and tasks simultaneously and autonomously.

• High levels of organization, attention to detail, and accuracy; committed to delivering quality outcomes.

• Collaborative, adaptable, and effective in building rapport across global, regional, and functional teams.

• Thrives in fast-paced, high-growth, and rapidly changing environments.

• Comfortable with ambiguity and skilled at defining operating models, processes, and roles while simultaneously implementing capabilities.

Preferred Skills:

• Experience supporting commercial launches in pharma strongly preferred. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

The Senior Manager, Clinical Systems is a hands-on technical leader responsible for the daily administration, support, and ongoing enhancement of core clinical systems, including eTMF and CTMS, as well as the implementation and optimization of future platforms that support clinical operations (e.g., RBQM, Study Start-Up, IRT/RTSM).

This role will actively perform and oversee system configuration, user management, periodic reviews, and validation activities, ensuring systems remain compliant, reliable, and inspection ready. The individual will work closely with Clinical Operations, Data Management, Regulatory, CSV, Quality, and external vendors to support business needs while maintaining GxP compliance. Key responsibilities in this role include:

• Act as the hands-on system owner/lead for assigned clinical systems, supporting daily operations and issue resolution.

• Perform user lifecycle management activities including provisioning, modifications, deactivation, and role-based access control.

• Execute and document periodic user access reviews and audit trail reviews in alignment with SOPs and regulatory requirements.

• Perform system configuration updates, including role updates, metadata changes, and system enhancements.

• Support and participate in system implementations, upgrades, and integrations, including hands-on validation activities.

• Execute release management activities, including impact assessments, regression testing, and coordination of deployments.

• Manage and execute change control activities, including documentation, risk assessment, and approvals.

• Troubleshoot system issues, coordinate with vendors, and track resolution through ticketing systems (e.g., ServiceNow).

• Generate and review system reports to support compliance, audit readiness, and operational oversight.

• Ensure systems operate in compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles.

• Support internal audits and health authority inspections by providing documentation, reports, and system walkthroughs.

• Partner with cross-functional teams to support end-user training, adoption, and process improvements.

Required Skills, Experience and Education:

• Bachelor's degree in information systems, Computer Science, Life Sciences, or related field.

• 5- 7 years of hands-on experience supporting clinical or GxP-regulated systems in a biotech or pharmaceutical environment.

• Veeva Vault administrator certification is strongly preferred.

• Strong experience with system administration, user access management, and periodic reviews.

• Hands-on experience supporting validated SaaS platforms and system implementations.

• Experience executing validation deliverables.

• Strong understanding of change control, release management, and system lifecycle processes.

• Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation approaches.

• Ability to troubleshoot issues and translate business needs into system configurations.

• Strong documentation and communication skills.

Preferred Skills:

• Hands-on experience with Transperfect Trial Interactive eTMF and eClinical Elluminate platfoms

• Experience with audit trail review, role-based security models, and inspection readiness.

• Familiarity with identity and access management tools (e.g., Active Directory, Azure Entra).

• Experience with ServiceNow or similar ticketing systems.

• Exposure to clinical data standards and regulatory submission processes. 

  #LI-Hybrid  #LI-YG1