Talent.com
Senior IT Business Systems Analyst - Regulatory
Senior IT Business Systems Analyst - RegulatoryApellis • Waltham, MA, United States
Senior IT Business Systems Analyst - Regulatory

Senior IT Business Systems Analyst - Regulatory

Apellis • Waltham, MA, United States
20 days ago
Job type
  • Full-time
Job description

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
  • Benefits and Perks :

    The targeted base salary range for this position is $94,000.00 - $141,000.00 per year. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions. per year. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions.

    Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit to learn more.

    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 or follow us on Twitter and LinkedIn

    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.

    Create a job alert for this search

    Regulatory Analyst • Waltham, MA, United States

    Related jobs
    Senior Applications Engineer, Manufacturing Systems IT

    Senior Applications Engineer, Manufacturing Systems IT

    Lantheus • Bedford, MA, United States
    Full-time
    Lantheus (NASDAQ : LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcome...Show more
    Last updated: 24 days ago • Promoted
    Information Systems Security Manager

    Information Systems Security Manager

    Georgia Tech • Lincoln, MA, United States
    Full-time +1
    Georgia Tech prides itself on its technological resources, collaborations, high-quality student body, and its commitment to building an outstanding and diverse community of learning, discovery, and...Show more
    Last updated: 25 days ago • Promoted
    Senior IT Business Systems Analyst - Regulatory

    Senior IT Business Systems Analyst - Regulatory

    Apellis Pharmaceuticals, Inc. • Waltham, MA, United States
    Full-time
    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 ...Show more
    Last updated: 30+ days ago • Promoted
    IT Business Systems Analyst

    IT Business Systems Analyst

    BAE Systems USA • Nashua, NH, United States
    Full-time
    The Functional Area (FA) Business Systems Analyst will be an engaged member of the IT & Security Business Partner team, providing support to our Finance, Contracts, HR, Legal and Communications are...Show more
    Last updated: 6 days ago • Promoted
    Senior Business Systems Analyst

    Senior Business Systems Analyst

    Wellness Pet Company • Burlington, MA, United States
    Full-time
    Senior Business Systems Analyst.Department : Information Technology.About the Wellness Pet Company.The Wellness Pet Company is on a mission to help the next generation of pet parents fulfill a shared...Show more
    Last updated: 20 days ago • Promoted
    Travel Board Certified Behavioral Analyst - School (BCBA) in Franklin Town, MA

    Travel Board Certified Behavioral Analyst - School (BCBA) in Franklin Town, MA

    AlliedTravelCareers • Franklin Town, MA, US
    Full-time
    AlliedTravelCareers is working with Aequor to find a qualified BCBA - School in Franklin Town, Massachusetts, 02038!.Aequor is now hiring a full-time Board Certified Behavior Analyst (BCBA) for the...Show more
    Last updated: 30+ days ago • Promoted
    Senior Banker I

    Senior Banker I

    BankTalent HQ • Walpole, MA, United States
    Full-time
    It is the responsibility of the Senior Banker I to represent Middlesex Savings Bank to the public and to their colleagues, and to promote the Bank's core values and mission.They accomplish this by ...Show more
    Last updated: 30+ days ago • Promoted
    Healthcare Enterprise Architect

    Healthcare Enterprise Architect

    Care New England Health System • Pawtucket, RI, US
    Full-time
    The Healthcare Enterprise Architect will be a key member of the IT team, responsible for providing strategic direction and technical expertise across multiple domains or technology areas.This role ...Show more
    Last updated: 24 days ago • Promoted
    Enterprise Software Systems Engineer

    Enterprise Software Systems Engineer

    Leidos Inc • Tewksbury, MA, United States
    Full-time
    Leidos' Security Enterprise Solutions (SES) operation is looking for a system engineer to lead development on our Ports and Borders enterprise networking products. This team is positioned at the for...Show more
    Last updated: 30+ days ago • Promoted
    Senior IT Business Systems Analyst - Regulatory

    Senior IT Business Systems Analyst - Regulatory

    Apellis Pharmaceuticals • Waltham, MA, United States
    Full-time
    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 ...Show more
    Last updated: 20 days ago • Promoted
    Remote Text Quality Evaluator

    Remote Text Quality Evaluator

    Outlier • Pawtucket, RI, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 2 days ago • Promoted
    Systems Quality Assurance I (Co-Op) - United States

    Systems Quality Assurance I (Co-Op) - United States

    Cisco Systems, Inc. • Maynard, MA, United States
    Full-time
    Please note this posting is to advertise potential job opportunities.This exact role may not be open today but could open in the near future. When you apply, a Cisco representative may contact you d...Show more
    Last updated: 17 days ago • Promoted
    Travel RN - Progressive Care Unit - Attleboro, Massachusetts - $1803 / week

    Travel RN - Progressive Care Unit - Attleboro, Massachusetts - $1803 / week

    Vetted Health • Attleboro, MA, US
    Full-time +1
    Job Opportunity : RN - Progressive Care Unit\n\nPosition Details\nSpecialty : RN - Progressive Care Unit\nLocation : Attleboro, Massachusetts\nFacility : Atlas MedStaff\nEmployment Type : Temporary\nCon...Show more
    Last updated: 4 days ago • Promoted
    IT Business Systems Analyst - ModelN Channel Management

    IT Business Systems Analyst - ModelN Channel Management

    1010 Analog Devices Inc. • Wilmington, MA, United States
    Full-time +1
    NASDAQ : ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologie...Show more
    Last updated: 30+ days ago • Promoted
    Remote FinTech Product Analyst - AI Trainer ($50-$60 / hour)

    Remote FinTech Product Analyst - AI Trainer ($50-$60 / hour)

    Data Annotation • Attleboro, Massachusetts
    Remote
    Full-time +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...Show more
    Last updated: 30+ days ago • Promoted
    IT Systems Analyst

    IT Systems Analyst

    Samprasoft • Framingham, MA, United States
    Temporary
    One temporary position is open, starting on a six-month contract with the possibility of extending for another six months. This position is 100% remote, and candidates can be located anywhere in the U.Show more
    Last updated: 3 days ago • Promoted
    Senior Salesforce Systems Analyst

    Senior Salesforce Systems Analyst

    UMass Lowell • Lowell, MA, United States
    Full-time
    UMass Lowell is committed to its Salesforce "Connected Campus" strategy.We have an exciting portfolio of Salesforce and partner technologies, including Education Cloud, Sales Cloud, Service Cloud, ...Show more
    Last updated: 30+ days ago • Promoted
    Analyst - Transportation

    Analyst - Transportation

    AmerisourceBergen Corporation (Cencora) • Mansfield, MA, United States
    Full-time
    Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...Show more
    Last updated: 30+ days ago • Promoted