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Senior IT Business Systems Analyst, Regulatory & Safety

Apellis
Waltham, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Sr, IT Business Systems Analyst, Regulatory + Safety

The Sr. IT Business Systems Analyst serves as the technology business partner to support and implement innovative process and system improvements to promote overall organizational efficiency and effectiveness. The role will be responsible for business requirements, business process definition/documentation, systems consulting, and system support management.

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. Additionally, this position supports the Apellis Safety organization who leverages full service functional partner and solution set.

Key Responsibilities:

  • Represent IT as the business analyst and technical SME
  • Understand business needs and identify solutions that align to overall business strategies. Review, analyze and evaluate business processes/systems and user needs.
  • Responsible for business systems consulting, project planning, prioritization, and implementation of deliverables, including implementations and operations.
  • Develop process documentation (current and to-be).
  • Document system, functional and business requirements, and objectives.
  • Technical SME for system activities for the system(s), enhancements, and integration projects. Coordinates support activities across vendor(s).
  • Interfaces with external vendors at all levels to manage the relationship and ensure the proper delivery of services.
  • Identify and troubleshoot operational issues and system issues.
  • Provide IT system support, including vendor operational and maintenance and oversight to the vendor's SLAs.
  • Represents IT in collaboration with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts.
  • Executes and facilitates GxP Computer System Validation activities for IT, including implementation, validation, maintenance. 
    • Responsible for computer system validation and change control documentation including: System Assessments, Validation Plan, User Requirements and/or Specifications, User Test Scripts (UAT), Traceability Matrix, Validation Summary Report
    • Support and maintain procedures and operational support processes

 Skills, Knowledge & Abilities:

  • Self-motivated and passionate to learn and adopt new technology and methodologies
  • 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
  • Customer Service oriented with attention to detail and quality
  • Must be able to effectively prioritize and plan. Ability to address multiple projects and adapt to changing priorities.
  • Strong communication and facilitation skills to develop consensus, clarity, and decision-making
  • Ability to communicate and work independently with cross-functional/inter-departmental teams and within the framework of the IT organization.
  • Understanding of technical IT issues to enable discussions with internal and external technical specialist
  • Strong understanding and working knowledge of FDA 21 CFR Part 11, ICH E6(R2)
  • Strong understanding and working knowledge of electronic submissions to Health Authorities.  Including eCTD Publishing and Submission process (FDA, EMA) and XML (backbone and format validation requirements). 
  • Experience working in a GxP environment(s) is required
  • Proficient in Microsoft Word, Excel, PowerPoint and other applications.

    Experience:

  • Experience with business process development and gap analysis, and business process mapping efforts
  • Experience in working with software vendors for support and maintenance
  • Experience designing, deploying and maintaining cloud-based GxP applications
  • Experience with GxP guidelines, Computer Software Validation (CSV), and IT SDLC
  • Experience with Veeva Vault RIM (Submissions, Submissions Archive) is highly preferred
  • Bachelor's degree in computer science, technology, operations, or related disciplines required.
  • 10+ years in a pharmaceutical/biotech or related environment required

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit https://apellis.com/careers/ to learn more.

Company Background:

 At Apellis, we are committed to developing transformative therapies for people living with a broad range of debilitating diseases by controlling complement, part of the body's immune system. Our work is rooted centrally at C3, which is the only target in the complement cascade that addresses all three pathways that can drive disease. Targeting C3 has broad platform potential to treat many diseases where patients have few or no treatment options available. Our programs across ophthalmology, nephrology, hematology, and neurology are further exploring what is possible by targeting C3.

Visit https://apellis.com/about-us/ut.html to learn more.

 EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment 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 that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

 

 

Apellis

Address

Waltham, MA
USA

Industry

Business

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