Seagen

Business Analyst IV - Regulatory

Corporate Functions - Bothell, United States

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

The functional Business Analyst / Sr. Business Analyst is a member of the IT Business Solutions team. This role has domain knowledge and is responsible for functional business analysis activities including driving requirement gathering, testing, and closely with business stakeholders and IT functions acting as subject matter expert where appropriate. This role provides ongoing process improvement, system enhancement, and support post-implementation.

Principal Responsibilities:

• Collaborate with various IT functions such as Business Systems, PMO, and Analytics to deliver solutions including process, technology, and report.
• Build knowledge on IT and assigned business organizations end-to-end processes.
• Own and maintain processes, documentation, and material while remaining compliant with regulatory guidelines.
• Manage the technology and process landscape for the assigned business organizations.
• Lead issue troubleshooting, resolve root cause, and update process and documentation to avoid similar future scenarios.
• Manage the activities and accountable for the outcome for complex and highly visibility efforts.
• Assist in portfolio activities and the creation of templates, process improvement, and framework for the Business Analyst team./li>

Additional responsibilities for Sr. Business Analyst:

• Lead strategic planning, tactical execution, and operationalization of various efforts aligned with a portfolio and organization objectives while remaining compliant with applicable regulatory guidelines.
• Troubleshoot complex issues and mobilize teams without direct authority Lead a portfolio of business process and entire solution lifecycle through planning, inception, implementation, and operations.
• Guide technical and architectural discussions that impacts processes and user experience.
• Identify opportunities to streamline and scale processes that align with organizational goals.
• Participate in the creation of business and financial cases as necessary.
• Delegate and supervise the work of vendors and contractors to meet business needs while abiding by situational guidelines.

Qualifications:

• Graduate with 5+ (10+ for Sr. Business Analyst) years of experience or Master’s degree with 3+ (5+ for Sr. Business Analyst) years’ experience.
• 5+ (10+ for Sr. Business Analyst) years in a Business Analyst role with proven experience in technology deliveries, process mapping, and process improvement.
• Experience in the pharmaceutical industry preferably in one or more of the following areas: Regulatory Affairs, Drug Safety, or Clinical Operations.
• Experience with Veeva Vault product suite preferably in Veeva RIM.
• Experience with GxP, ICH, 21CFR, Part 11 regulations, Annex 11, GDPR, or CCPA.
• Experience in Regulatory processes – Submissions, Publishing, Health Authority Interactions and Labeling.
• Demonstrated technical understanding of application architecture including various technologies and complexity such as SaaS solutions, web applications, repositories, relational databases, and reporting.
• Excellent communication skills, including the ability to interface and influence internal and external partners at multiple organization levels.
• Strong interpersonal and negotiation skills, with a high degree of self-motivation, and ability to work independently with minimal supervision.
• Ability to proactively plan, organize, deliver with limited oversight, prioritize, and quickly adapt to changing situations.
• Proficient in essential tools such as Microsoft Project, PowerPoint, Visio, etc.

Additional qualification for Sr. Business Analyst:

• Hands on experience operationalizing end to end business processes.
• Evaluates business processes, identifies needs, and develops strategies to maximize opportunities for a specific business function within Seagen.
• Has experience on release management for IT applications with a specific focus on SaaS applications.

Preferred Qualifications:

• Familiarity with biotech/pharmaceutical business processes and applications
• Master's in business and Administration (MBA)
• Experience with one or more of the following tools: Veeva CRM, Veeva Vault product suite, preferably Veeva RIM
• Experience in one or more of the following organizations: Research, Manufacturing, Development, Commercial, Human Resources, or Information Technology

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 08/05/2022