SUMMARY OF POSITION

Contribute to the development / configuration and implementation of informatics systems and programs to support the business functions of Alvogen in the US. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management.

ORGANIZATION STRUCTURE

This position reports to the Director, Business Operations within Alvogen Information Technology function. This position does not have direct reports and is not assigned to additional groups, committees, or councils.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Contribute and provide where applicable, informatics solutions architecture expertise, project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications and solutions to meet business needs. Provide system support, system validation and change control process guidance and expertise. Contribute to the development of information system roadmaps.
• Work with the business users to define and document user information needs, research innovative product value proposition and collect ideas for future roadmaps and planned projects; contribute to the develop business cases to secure the necessary funding and resources for their successful implementation.
• Provide the interface between the business and the technology providers to deliver R&D information applications solutions.
• Works closely with LMS, EDMS, EQMS, and LIMS subject matter experts, users, stakeholders, and vendors to gather and document requirements in support of periodic releases or change requests; following established SOP's.
• Designs, configures, customizes, and develops LMS, EDMS, EQMS, and LIMS applications and features to meet business requirements with a preference for simple solutions that leverage out-of-the-box system functionality as much as possible.

QUALIFICATIONS

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university):

• Bachelor's Degree with 5 or More Years applications support and operation in the pharmaceutical industry within the appropriate regulatory guidelines.

Or

• Associates Degree with 7 or More Years applications support and operation in the pharmaceutical industry within the appropriate regulatory guidelines.

Experience Qualifications:

• 5 or More Years experience in systems development and operation in the pharmaceutical industry within the appropriate regulatory guidelines. Required.

• Experience in working within the framework of 21 CFR Part 11, SDLC, GAMP, ICH. preferred

Experience as an application administrator for any of the following systems highly desirable:

1. STARLIMS
2. QUMAS EDMS
3. QUMAS EQMS
4. ComplianceWire

GMP DECISION-MAKING AUTHORITY

None

We are an EEO employer, including disability and vets.