· Job facts
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 Product Development Safety (PDS) organization is embarking on a transformational initiative to reshape the pharmacovigilance landscape at Roche by incorporating state-of-the-art innovative technologies. The position will be responsible to lead the initiative from the PD Informatics, partnering effectively with the business to define the process, manage the vendor to deliver to the business requirements and plan for the lifecycle of the solution.
The IT Business Partner (ITBP) 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 Product Development Safety (PDS) organization 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
Preferred location for this position is South San Francisco. Other location could be Welwyn (UK).
You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
The Ideal Candidate:
Has business domain knowledge in Pharmaceutical and Biotech Safety 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 with 8-10 years of experience in related field, or an MA or MS and post-graduate coursework with 4-6 years of work experience is desirable. At least 5-8 years of related experience in the safety domain, knowledge of processes and systems, computer systems validation, GCP and FDA 21CFR Part 11
· 7+ years business systems analysis and support experience with various types of Software Development Life Cycle methodologies.
· Experience in delivering complex large programs collaborating across several workstreams consisting of functional and informatics team
· Demonstrated experience in collaborating with safety business domain experts in developing technology strategy and roadmap
· Experience in working with technical teams to deliver technology solutions to meet business objectives for safety business function
· Knowledge of the pharmacovigilance regulations 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-- ability to communicate complex information, issues, and potential solutions across the enterprise.
· Solid understanding of global pharmacovigilance regulations
· Ability to travel 25-30%
Roche is an equal opportunity employer.
Information Technology, Information Technology > IT Business Process Management, Consulting and Support
· 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.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.