Principal Solution Architect - Regulatory Informatics

South San Francisco
California, United States of America

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The Position

Principal Solution Architect, Regulatory Informatics

The Regulatory Informatics team is looking for a highly skilled and experienced Principal Solution Architect with proven ability to apply architecture knowledge of systems and tools, strategic thinking and problem solving skills across the Regulatory Informatics domain and become a full-time member of the management team.

Responsibilities Include:

  • Assess and define the solution architecture for key initiatives and programs that will enable an architecture for Regulatory that will be, sustainable, stable, scalable and able to utilize the most innovative technologies to support our business stakeholders
  • Develop robust and achievable technology lifecycle roadmap plans for Regulatory solutions that support dependable solution maintenance, enhancement (M&E) and change control processes
  • Define the principles that guide technology decisions in support of the Regulatory business
  • Analyze the current technology environment to detect critical deficiencies and recommend solutions
  • Analyze enterprise business context/needs (trends and business strategy) to derive technical architecture
  • Design and lead the implementation of an ETA based on business requirements and IT strategies/trends, and rectify gaps and pain points within the current state
  • Assist with designing the governance activities associated with ensuring ETA compliance
  • Stay abreast of emerging technologies and trends and how to apply them to benefit the business
  • Devises unusual or radically different approaches to deliver value added solutions
  • Analyzes previously used concepts, processes or trends and devises new efficiencies not obvious by others
  • Understand, advocate and augment the principles of business and IT strategies
  • Create and deliver compelling presentations to articulate the strategies and roadmaps and various levels in the Organization
  • Oversee or consult on technical architecture implementation activities, particularly for new and/or shared infrastructure solutions
  • Oversee and facilitate the evaluation and selection of hardware and software technology and product standards, and the design of standard configurations/implementation patterns
  • Consult on application or infrastructure development projects to fit systems or infrastructure to the technical architecture
  • Identify the organizational impact and financial impact of the ETA
  • Document necessary technical architecture design and analysis work, possibly including project postmortem documentation and metric collection
  • Support the Technical Lead role providing guidance, mentorship and oversight
  • Understand, advocate and augment the principles of the Regulatory business and IT strategies
  • Defines direction for technology and/or Regulatory business IT solutions
  • Distills complex issues and ideas down to simple, comprehensible terms
  • Delivers presentations with focus and poise
  • Develops and facilitates Regulatory strategic plan and ensures implementation of industry best practices in support of the Regulatory business strategy.
  • Initiates and organizes demonstrations which provide subject matter expertise and identify technological strategies that will support the achievement of Regulatory business goals.
  • Define proposals, champions and gather sponsorship for implementing Regulatory IT strategy and roadmap.
  • Work directly with the Regulatory Business and cross-functional project teams
  • Flexibility to work outside normal working hours to support a global solution implementation across different time zones

For this position, you bring the following qualifications:

  • 12 - 15 years experience with Bachelor’s degree in Computer Science, Engineering or equivalent; 10 - 13 years experience with Masters; 7 - 10 years experience with PhD/JD
  • Has in depth and expert level knowledge in multiple technology domains, 2 or more, and is an occasional speaker at conferences on either technology or leadership
  • In depth knowledge in multiple business domain e.g. Commercial, PT, PD and Business Support
  • Demonstrated ability to influence business partners at the VP and Sr. VP level
  • Has successfully delivered on multiple projects in the past using established technology standards as well as emerging ones preferably in a regulatory environment
  • Proven track record of defining an architectural system landscape vision, and implementing a transformational and simplified system landscape focussed on seamless information flows and cross-functional data standardization.
  • Influences strategy/direction in one or more functional areas such as commercial, PD, PT or Enterprise, etc.
  • Influencing capabilities up to VP and/or Sr. VP levels in the business and Informatics areas
  • Influences Industry trends by working with vendors
  • Proven track record of designing software solutions and applying good practices of Solution Architecture
  • Relevant business knowledge, especially of business processes, and knowledge of a regulated GxP industry required
  • Knowledge of information and system landscape in Regulatory Affairs, is a plus
  • Knowledge of process and how to develop and maintain system landscapes are required
  • Fluent English skills and ability to travel as required up to 25% of the time


Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.

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