Our Product Development Informatics (PDIX) is co-creating a better future for patients through innovative technology and information. We are seeking mission-driven, ardent, self-starting, creative individuals to join us in this effort. We are an agile organization that brings together great people who are passionate about technology innovation, and who thrive in dynamic, cross-functional, and mission-driven teams.
The IT Business Partner for PD Registrations and Safety will help shape a new future of Regulatory and Safety in Roche and Genentech through information and technology partnering. They will lead strategies aligned to the mission of Regulatory and Safety organizations to manage the licenses of the products and to advance the safety profiles of the products through its lifecycle.
As an Informatics Business Partner you will drive business opportunities enabled by information technology.
Responsibilities of ITBP in PDIX Registrations and Safety:
Provide strategic direction, prioritization and mobilization of resources aligned to shared business objectives with respective areas
Actively participate in strategy setting meetings in PDR and PDS organizations and across informatics
Provide input into Quarterly Business Reviews and the Registration and Safety system portfolio
Take a leadership role that educates, advises and challenges to enrich business area strategy for the benefit of the whole
Negotiate and influence to ensure the right product owners are assigned to key initiatives
Work with business, data and insights & infrastructure teams to architect, design, prototype, and develop solutions that enable quality decisions.
Identify business opportunities and work with business and informatics partners to architect, design, prototype and deliver continually improved products
The Ideal Candidate:
Has business domain knowledge in Pharmaceutical and Biotech Quality, Safety, Regulatory and Global Health Authority Regulations. Nurtures and develops a business savvy consultative and value driven partnership. Champions Informatics Strategy and the implementation of core platforms. Well-networked, awareness of Group processes, cross-org perspective, connects the dots, adds the external perspective. Understands market challenges and competitive issues. Exhibits intellectual curiosity and integrity.
BA or BS in life science, informatics, business or equivalent. MA or MS and post-graduate coursework is desirable
8+ years experience leading technical product portfolio, applications and or data analytical systems
At least 5-8 years of related experience, domain knowledge regulatory processes and systems, computer systems validation, GCP, and FDA 21CFR Part 11
5+ years business systems analysis and support experience with various types of Software Development Life Cycle methodologies
Demonstrated experience in collaborating with regulatory business domain experts in developing technology strategy and roadmap
Experience in working with technical teams to deliver technology solutions to meet business objectives for regulatory business function
Knowledge of the regulatory submission processes and supporting technical solutions
Ability to rapidly understand business requirements and communicate business expectations to cross-functional project/delivery teams. Develop advanced technological ideas and guide their development into a final solution
Ability to lead cross functional collaborative team environments, provide innovative solutions to complex business problems
Strong communication skills (nice to have) -- ability to communicate complex information, issues, and potential solutions across the enterprise
Solid understanding of FDA, and Global Health Authority Regulations
Ability to travel up to 25%