Senior IT Business Systems Analyst - Regulatory

Apellis Pharmaceuticals; Waltham (MA); On-site; USD 94,000 - 141,000; Full time

Benefits offered by this job

401(k) plan with company match

Flexible time off

Paid family leave

Disability and life insurance

Job summary

A leading biopharmaceutical company is seeking an IT Business Systems Analyst to drive strategic technology initiatives and oversee regulatory systems. This hybrid role based in Waltham, MA, requires 5+ years of experience in the pharma industry, strong communication skills, and a bachelor's degree in a relevant field. The role includes documenting business processes and ensuring compliance with regulations.

Qualifications

• 5+ years in a pharmaceutical/biotech environment required.
• Experience in GxP environment and software validation.
• Experience with business process mapping and gap analysis.

Responsibilities

• Collaborate with business stakeholders to document processes.
• Analyze business needs and identify strategic solutions.
• Manage support activities and incident resolution.

Skills

Regulatory operations knowledge

Customer service orientation

Attention to detail

Team-oriented

Problem solving capability

Strong communication skills

Cross-functional teamwork

Proficient in Microsoft Office

Education

Bachelor's degree in computer science or related disciplines

Tools

Cloud-based applications

Veeva Vault

IQVIA RIMSmart

Job description

Overview

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. Location: Hybrid Based Waltham, MA.

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

Benefits

• The targeted base salary range for this position is $94,000.00 - $141,000.00 per year (base salary only). The final salary offered may vary based on individual qualifications, business needs, and current market conditions.
• Comprehensive benefits package including a 401(k) plan with company match, inclusive family building benefits, flexible time off, paid family leave, disability and life insurance, and more. Visit https://apellis.com/careers/benefits/ to learn more.

Company Background

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that develops life-changing therapies and has products targeting C3 with programs underway.

EEO Statement

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis prohibits discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex, gender, age, disability, citizenship, veterans status, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, or other protected characteristics. For San Francisco postings: we will consider qualified applicants with arrest and conviction records.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities. Duties may change at any time with or without notice.