Responsibilities
- Participate in project planning, execution, risk management, and quality assurance across multiple concurrent initiatives.
- Ensure solutions meet regulatory and data privacy requirements, including GxP, 21 CFR Part 11, HIPPA, GDPR and data integrity standards.
- Apply and follow appropriate delivery methodologies (Agile, Waterfall, hybrid) based on project needs and compliance considerations.
- Collaborate with business, technical teams and vendors to ensure accurate translation of business requirements into technical solutions.
- Assume accountability throughout all phases of system development lifecycle from ideation and planning through production support and troubleshooting.
Requirements
- Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields
- At least 5 years’ experience delivering IT projects within a regulated industry, ideally pharmaceuticals or life sciences
- Familiarity with multiple functional domains (e.g. Quality, Regulatory, Medical, Commercial and/or Clinical)
- Knowledge of GxP compliance, validation practices and regulated system requirements
- Experience with large-scale, global implementations
- Experience with enterprise technologies such as Veeva Vault, Salesforce.com, Microsoft Dynamics
- Proficient in MS Office Suite
Benefits
- 401K with company match
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Life & Disability Insurance
- Concierge Services
- Long Term Incentive Program (subject to job level and performance)
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
Work Arrangement
Remote (City/Region)
Additional Information
- Requires up to 10% domestic and international travel
