Computer System Validation Remote Jobs in New Jersey

Job Description Brief description of the position Reporting to the US head of IT, IT Architect is a strategic technology leader responsible for overseeing the entire IT architecture and providing technical oversight on all projects to all Calliditas US business functions. The IT Architect is a trusted IT partner to the business, who can actively lead the identification and architecture of technical solutions from strategy, design, integration, testing and deployment. This individual has strong leadership and communication skills on complex technological topics, working alongside with Calliditas senior management, the business teams, delivery counterparts, and outside vendors.

Based in Jersey City or New York, with flexibility for remote work when required, the position has a good understanding of the pharmaceutical business in the US. The Director is responsible for executing the IT strategy, coordinating with IT vendors, program managing all IT projects, and prioritizing the demand ensuring IT solutions and services meet customer needs. Collaboration with Global IT and HQ to make sure everything done in the US is in line with the overall IT strategy is an important aspect.

The ideal candidate is highly motivated with necessary technical background, very responsive and results oriented individual with good relationship development and communication skills, and strong project management experience. Tasks and responsibilities/accountabilities About 15 key Applications including Veeva, Revo, Tableau, Concur, Salesforce Marketing Cloud, and MS Dynamics. Key Business areas includes Sales, Marketing, Patient Services, Market Access, Medical Affairs, Regulatory, Quality, Finance, HR, and Legal About 100 employees and 50 field sales reps About 15 third party vendors All support resources are from managed services providers Tasks and responsibilities/accountabilities KEY DUTIES AND RESPONSIBILITIES: % of Time or Importance 1.

IT Architecture - Define, architect, and manage the enterprise IT systems architecture and ensure that the architecture across the ecosystem is secure, compliant, efficient, and scalable and that it continually supports the corporate business strategy. Ensure understanding of technical and non-technical requirements to produce the best technical solution architectures available based on time, scope, and budget. Produce technical documentation, including design plans, solution architecture diagrams, data flow diagram, and data dictionary, to solidify data/information consistency across the organization 2.

35% 3. System Implementation - Oversee all system implementations, data integrations, data warehousing, business intelligence reporting, and master data management. Lead IT technical discussions and collaborate with business on solution implementation.

Work with internal subject matter experts to understand current and future execution capabilities and identify improvement opportunities. Identify risks and present project updates to the leadership team. 4.

25% 5. Vendor Management - Be part of the vendor selection process, representing IT to drive technical discussions, reviewing proposals and contracts, and providing feedback to help make decisions that better meet buisness needs. Manage third party vendor's development teams to delivery technical/data projects.

6. 25% 7. Operational support and delivery excellence - Monitor systems, performance and troubleshoot problem areas as needed, and provide technical insights and facilitate issue resolutions among internal business stakeholders and vendor's managed services teams.

8. 10% 9. Assistance in project portfolio management: Provide input to long range strategic plan, IT Roadmap and project portfolio.

Assist Head of IT in the creation and management of the IT budget. 10. 5% Competence requirements for the position (education and experience) Minimum or equivalent of a BA/BS degree is required.

A least 10+ years of relevant IT experience, 8+ years in DW/BI space, and minimum 5 years in IT with Pharmaceutical companies. Experience with pharmaceutical or Biotech commercial IT is a plus. Experience in managing third party solutions and services Understanding of the pharmaceutical business, general business processes, and the systems environment in place to support those processes.

Experience with multiple and diverse application environments including Sales, Marketing, e-Marketing, Market access, Regularity, Medical Affairs, Finance, and Business Intelligence processes and applications. Experience with Veeva CRM and Veeva is a plus. Good understanding of IT landscape, policies, practices and systems.

Have a superior understanding of data architecture and Project management and working understanding of the overall technical architecture of the systems and how it fits into the overall IT landscape. Have a good understanding of the IT environment and knowledge about IT trends and directions. Experience in customer service, and with computer systems validation for both GxP and non-GxP platforms.

Experience communicating with business users. Demonstrated ability to stay current with evolving technology and regulations. Essential Skills and Abilities Proven technical, leadership and management skills with the ability to manage simultaneous priorities and changing deadlines.

Able to present a professional image of IT to all stakeholders through verbal and written interactions. Exceptional customer facing skills and abilities. Excellent vendor management skills.

Proven experience with managing external, global, third party Managed Services Providers and software vendors. Strong analytical, problem-solving, persuasion, and conflict resolution skills with a strong sense of urgency. Excellent interpersonal, oral and written communications skills with the ability to effectively interact with customers, associates and at all levels of management.

Ability to work with independently and make decisions independently.