Director, Regulated & Commercial Applications

Inventiva Pharma; Northern (KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Inventiva Pharma is seeking an experienced Application Manager to join its US East Coast-based IT applications team. The role focuses on regulated business applications across Clinical Operations, Regulatory Affairs, Quality, and Pharmacovigilance, with future involvement in CRM platform implementation and commercial systems.

The candidate will work with stakeholders in the United States and Europe, ensuring systems are reliable, compliant, and aligned with evolving business needs.

Qualifications

• CRM experience is a strong asset for this role.
• Experience with Clinical, Regulatory, Quality or Pharmacovigilance applications.
• GxP requirements, Computer System Validation, 21 CFR Part 11 and Annex 11 knowledge.
• Experience with SaaS solutions and external software vendors.
• Exposure to CRM platforms in healthcare/biotech/pharma environments.
• Strong organizational skills and ability to manage multiple priorities.
• Excellent communication and a pragmatic, service-oriented approach.

Responsibilities

• Manage a portfolio of business-critical applications used by regulated functions.
• Coordinate lifecycle activities including upgrades, vendor releases, testing and user support.
• Ensure systems remain fit for purpose and meet business requirements.
• Act as primary liaison between business users, vendors and IT for assigned applications.
• Ensure systems are operated in accordance with GxP requirements.
• Coordinate validation, change controls, risk assessments and periodic reviews.
• Maintain documentation and audit readiness.
• Participate in inspections and audits involving IT-controlled systems.
• Build relationships with Quality, Regulatory Affairs, Clinical Operations, Pharmacovigilance and Medical Affairs.
• Translate business needs into practical system improvements and solutions.

Skills

CRM experience

GxP compliance

21 CFR Part 11

Annex 11

SaaS solutions

Vendor management

CRM platforms

Organizational skills

Communication skills

Education

Bachelor’s in Information Technology, Computer Science, Software Engineering, Information Systems or a related technical discipline

Job description

Inventiva Pharma is seeking an experienced Application Manager to join its US East Coast-based IT applications team. The role focuses on regulated business applications across Clinical Operations, Regulatory Affairs, Quality, and Pharmacovigilance, with future involvement in CRM platform implementation and commercial systems.

The candidate will work with stakeholders in the United States and Europe, ensuring systems are reliable, compliant, and aligned with evolving business needs.