Apellis
IT Business Systems Analyst - Regulatory
Apellis, Waltham, Massachusetts, United States, 02254
It Business Systems Analyst - Regulatory
The IT Business Systems Analyst acts as a strategic technology business partner to support and implement innovative process and system improvements to promote overall organizational efficiency and effectiveness, with a focus on Regulatory systems. This role ensures documentation of business requirements and business process definitions; systems consulting; and systems support management. This individual will provide oversight and continuity of the detailed system processes and configurations within and across software applications used at Apellis. Position will work with all levels of the business including business partners, technology teams, and external vendors. Position will focus on business process documentation and business requirements, implementing and supporting Regulatory business solutions. Location: Hybrid Based Waltham, MA Key Responsibilities: Collaborate with business stakeholders to understand, define, and document business processes and functional requirements Represent IT as a business analyst and technical SME, analyzing business needs, and identifying solutions that align to strategic goals Review, analyze, and evaluate business systems for their applicability to identified user needs. Develop and maintain documentation for functional requirements and detailed business system processes Manage and coordinate support activities and incident resolution across internal teams and external personnel, including managed services vendor(s). Troubleshoot procedural, operational and configuration issues, and proactively document process improvements. Ensure IT compliance by collaborating with Quality Validation and business stakeholders on computer system validation (CSV) and regulatory requirements (GxP). Skills, Knowledge & Abilities: Thorough knowledge of Regulatory operations and related business functions, including Submissions, Publishing (Gateway,eCTD), and Labeling Customer Service oriented with a keen attention to detail and quality Ability to be empathetic to business user needs, and seeing things from their perspective Team-oriented and generous in sharing knowledge and enabling others Reliable, consistent, and proactive Capable of day-to-day problem solving and taking responsibility for decisions Must be able to effectively prioritize and plan. Ability to address multiple projects and adapt to changing priorities. Strong verbal and written communication skills Ability to communicate and work with cross-functional/inter-departmental teams and within the framework of the IT organization, as well as to work independently. Proficient in Microsoft Word, Excel, PowerPoint and other applications. Experience: Experience with business process development and gap analysis, as well as business process mapping efforts Experience designing, deploying, and maintaining cloud-based applications Experience working in a GxP environment, including change control, change management, Computer Software Validation (CSV) Experienced in working with software vendors for support and maintenance Bachelor's degree in computer science, technology, operations, or related disciplines required. 5+ years in a pharmaceutical/biotech or related environment required Highly desired: Experience with Veeva Vault (RIM Submissions, Submissions Archive, and Registrations) Experience with IQVIA RIMSmart Company Background: Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit https://apellis.com/careers/benefits/
The IT Business Systems Analyst acts as a strategic technology business partner to support and implement innovative process and system improvements to promote overall organizational efficiency and effectiveness, with a focus on Regulatory systems. This role ensures documentation of business requirements and business process definitions; systems consulting; and systems support management. This individual will provide oversight and continuity of the detailed system processes and configurations within and across software applications used at Apellis. Position will work with all levels of the business including business partners, technology teams, and external vendors. Position will focus on business process documentation and business requirements, implementing and supporting Regulatory business solutions. Location: Hybrid Based Waltham, MA Key Responsibilities: Collaborate with business stakeholders to understand, define, and document business processes and functional requirements Represent IT as a business analyst and technical SME, analyzing business needs, and identifying solutions that align to strategic goals Review, analyze, and evaluate business systems for their applicability to identified user needs. Develop and maintain documentation for functional requirements and detailed business system processes Manage and coordinate support activities and incident resolution across internal teams and external personnel, including managed services vendor(s). Troubleshoot procedural, operational and configuration issues, and proactively document process improvements. Ensure IT compliance by collaborating with Quality Validation and business stakeholders on computer system validation (CSV) and regulatory requirements (GxP). Skills, Knowledge & Abilities: Thorough knowledge of Regulatory operations and related business functions, including Submissions, Publishing (Gateway,eCTD), and Labeling Customer Service oriented with a keen attention to detail and quality Ability to be empathetic to business user needs, and seeing things from their perspective Team-oriented and generous in sharing knowledge and enabling others Reliable, consistent, and proactive Capable of day-to-day problem solving and taking responsibility for decisions Must be able to effectively prioritize and plan. Ability to address multiple projects and adapt to changing priorities. Strong verbal and written communication skills Ability to communicate and work with cross-functional/inter-departmental teams and within the framework of the IT organization, as well as to work independently. Proficient in Microsoft Word, Excel, PowerPoint and other applications. Experience: Experience with business process development and gap analysis, as well as business process mapping efforts Experience designing, deploying, and maintaining cloud-based applications Experience working in a GxP environment, including change control, change management, Computer Software Validation (CSV) Experienced in working with software vendors for support and maintenance Bachelor's degree in computer science, technology, operations, or related disciplines required. 5+ years in a pharmaceutical/biotech or related environment required Highly desired: Experience with Veeva Vault (RIM Submissions, Submissions Archive, and Registrations) Experience with IQVIA RIMSmart Company Background: Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit https://apellis.com/careers/benefits/