Director, Regulated & Commercial Applications

Inventiva Pharma; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Inventiva is seeking an experienced Application Manager to join the US East Coast IT applications team. You will own a portfolio of regulated business applications used by Clinical Operations, Regulatory Affairs, Quality and Pharmacovigilance, and help implement a future CRM platform.

Reporting to the IT Director, you will coordinate validation, change controls, audits, vendor management and continuous improvements while collaborating with teams in the US and Europe.

Qualifications

• GxP knowledge, CSV, 21 CFR Part 11 & Annex 11 are essential.
• Experience with regulated life sciences applications (biotech/pharma).
• CRM experience is a strong asset.
• Experience with SaaS & external software vendors.
• Excellent communication and organizational skills.
• Comfort working remotely from the U.S. East Coast.

Responsibilities

• Manage a portfolio of business-critical applications for regulated functions.
• Coordinate lifecycle activities: upgrades, vendor releases, testing, user support.
• Ensure systems stay fit for purpose and compliant with GxP.
• Serve as main liaison between users, vendors, and IT for assigned apps.
• Support validation, change control, risk assessments and reviews.
• Maintain documentation to support audits and inspections.
• Collaborate with Quality, Regulatory, Clinical Ops, Pharmacovigilance and Medical Affairs.
• Translate business needs into practical system improvements.
• Lead or contribute to application projects and CRM initiatives.
• Coordinate external partners and evaluate CRM platforms.
• Evolve the applications landscape and simplify processes.

Skills

CRM experience

GxP knowledge

Computer System Validation

21 CFR Part 11

Annex 11

SaaS experience

Vendor management

Communication skills

Remote work capability

Education

Bachelor’s in Information Technology / Computer Science / Software Engineering / Information Systems

MBA or other advanced degree

MS

PharmD

PhD

Tools

SaaS tools

Job description

Inventiva is seeking an experienced Application Manager to join the US East Coast IT applications team. You will own a portfolio of regulated business applications used by Clinical Operations, Regulatory Affairs, Quality and Pharmacovigilance, and help implement a future CRM platform.

Reporting to the IT Director, you will coordinate validation, change controls, audits, vendor management and continuous improvements while collaborating with teams in the US and Europe.