Product Lead Engineer - Regulatory Insights and Experience
- India
- Permanent
- Full-time
- Responsible for overall Engineering and Technology architecture definition, roadmap, and technical decisions for the product in coordination with the Product Owner, Product Group Engineer and BU Architect. Accountable for ensuring that technical implementation is aligned to the BU Architecture vision, economic framework and business needs
- Work closely with the Business Product Manager to define Product strategy/vision
- Work with squads to problem-solve technical challenges and implement solutions, using the squad technology strategy as a guide; is “hands-on-keys” coding while also supporting system/design/code reviews for squad –inclusive of assembling, writing and approving enablers
- Drive development and selection of technical solution options (from the approved list of solutions) and test concepts / potential solutions with users
- Negotiate technology options with business partners and collaborate with platform/product teams to find opportunities to leverage platforms
- Lead development and review cadence, align tech landscape across squads to promote reusability, scalability and modularity
- Supervise product / platform developments and drive leading engineering practices for higher tech quality
- Own the technology lifecycle management and Product API catalogue, including the definition, creation, and maintenance of technical interfaces
- Observe technology trends across the industry and conduct research spikes for new capability and innovation opportunities
- Ensure timely adoption of new technologies and innovation, select and resource ideas to explore via ideation sessions where vital
- Help Product Owners/Lead Engineers prioritize technical backlogs (across squads) and coach / mentor product and squad members
- Works with squads and other Product Lead Engineers to manage risks and solve, escalate, and track cross-product dependencies and impediments
- Be the single point of contact for ISRM, TQ (Q-CSV), vendors, and enterprise platform owners
- A minimum of two to four (2-4) years of relevant IT and business experience is required
- Knowledge of global regulatory affairs, regulations, computer systems validation requirements, current industry regulatory technology landscape, including knowledge of vendors, systems and what is new & upcoming in this space and all vital compliance requirements for workflow, reporting, and information custody for medicinal products companies
- Experience leading the selection, build, and integration of platforms including data management, API architecture/design, and Cloud Native technologies
- Prior track record of owning products / platforms over their lifecycle in a multi-team context
- Prior track record of gathering requirements and translating into a product / platform vision through deep expertise in development, engineering, and UX
- Knowledge in at least one coding language (i.e. C/C++, C#, Python, Java) with code review experience
- Excellent understanding of Global Regulatory Affairs systems, processes, and system/data integrations with downstream systems for analytics, compliance, and dashboarding
- Strong verbal and written communication skills with ability to confidently present complex information to all levels of the organization is required
- Sufficient understanding of the Regulatory business needs, including sufficient knowledge of business processes, relevant value drivers, and industry trends
- Maintain and advance a positive team culture and support an authentic, open, and broad environment that enhances diverse experiences and perspectives
- Strong understanding and knowledge about cloud computing technologies and platforms
- 20% Domestic Travel
- Experience in the use of AI/ML within a pharmaceutical business environment
- Experience in the use of Generative AI and Large Language Models.
- Experience in the use of Agile methodology, process engineering and prototyping tools