Lead R&D Technologist - GenAI

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS.
As a Lead R&D Technologist you are expected to act as the functional lead and subject matter expert for GenAI-enabled content authoring initiatives across clinical development and regulatory submissions. This role combines deep domain expertise, business analysis leadership, and GenAI solution design. You are expected to combine deep domain expertise with GenAI solution design, acting as a trusted advisor to clients and owning end-to-end business analysis, prompt strategy, validation, and delivery oversight. You will be accountable for ensuring that AI-generated outputs are scientifically accurate, regulatorily compliant, and operationally scalable. You will also contribute to the development of new offerings, translating ideas into prototypes and supporting full-scale client implementations.
Client Engagement and Leading Requirement Gathering:

• Lead client workshops and stakeholder discussions to understand authoring objectives, regulatory constraints, and operating models.
• Translate business needs into detailed functional requirements, user stories, acceptance criteria, and process flows.
• Identify upstream and downstream documents, data sources, and systems; create network maps and prioritization frameworks to guide implementation.
• Act as the primary interface between client SMEs, internal domain teams, and GenAI/engineering teams.

GenAI Content Authoring Solution Design:

• Own the digitization and GenAI enablement strategy for clinical and regulatory documents.
• Define document prioritization frameworks based on submission criticality, reuse potential, and automation feasibility.
• Guide configuration of document templates with static and dynamic text aligned to sponsor and regulatory requirements.

Prompt Strategy & Content Validation:

• Lead prompt design and prompt governance in collaboration with blueprint engineers and AI teams.
• Define validation criteria covering scientific accuracy, regulatory tone, completeness, and traceability.
• Review and approve AI-generated content from a scientific and regulatory standpoint.
• Identify and mitigate GenAI risks (hallucinations, outdated guidance, bias).

Delivery & Team Enablement:

• Mentor Senior and Junior Business Analysts on content modeling, GenAI use cases, and regulatory interpretation.
• Support planning, prioritization, and client communications throughout the engagement lifecycle.
• Coordinate closely with technology, blueprint engineering, and domain SMEs to ensure smooth delivery.
• Contribute to internal capability building, thought leadership, and reusable accelerators

Domain & AI Expectations:

• Deep familiarity with clinical and regulatory documents (Protocols, CSRs, IBs, SAPs, DSURs, eCTD).
• Ability to critically assess and validate AI-generated scientific content

Education:

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Clinical Research, or related field.

Experience:

• Minimum work experience of 5 years in similar and/or life science companies/firms
• Strong understanding of clinical development and regulatory submission processes.
• Proven experience building solutions in drug development areas such as clinical/regulatory document authoring, medical writing etc or/and GenAI based initiatives in clinical/ life sciences space
• Strong understanding of clinical development processes, trial methodology, and regulatory writing requirements.
• Hands-on familiarity with global regulatory guidance and submission standards
• Hands-on experience with drug development and regulatory documents such as p rotocols, IBs, ICFs, CSRs, SAPs, DSURs & eCTD Modules 1-5
• Deep familiarity with document structures, templates, and submission-ready standards.

AI & Technology Fluency:

• Familiarity with document basics of (Gen)AI, automation tools, or prompts etc.
• Hands on experience with GenAI-based content generation project
• Ability to assess and validate AI-generated scientific content for accuracy and regulatory appropriateness.

Skills & Competencies:

• Critical thinking and problem-solving skills with the ability to distill complex concepts into clear, actionable insights for clients
• Excellent client-facing communication and analytical skills.
• Experience managing deliverables within large and complex programs
• Understanding of Agile methodologies and project lifecycle ma nagement
• Strong stakeholder management and communication skills
• Fluency in English
• Client-first mentality
• Intense work ethic
• Collaborative spirit and problem-solving approach

How you'll grow:

• Cross-functional skills development & custom learning pathways
• Milestone training programs aligned to career progression opportunities
• Internal mobility paths that empower growth via s-curves, individual contribution and role expansions

Perks & Benefits:
At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well-being, financial future, time away, and professional development. With robust skills-building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you'll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in Germany , visit ZS Germany office locations | Where we work | ZS .
Hybrid working model:
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Travel:
Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
Considering applying?
At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.
If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
To complete your application:
Candidates must possess or be able to obtain work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
NO AGENCY CALLS, PLEASE.
Find Out More At:
www.zs.com