Job Description

[Employer hidden — sign up to reveal] 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. [Employer hidden — sign up to reveal]ers 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.

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.

Key Responsibilities

• 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.
• 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.
• 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• Identify and mitigate GenAI risks (hallucinations, outdated guidance, bias).
• 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.

Qualifications

Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, or related field.

Experience: Minimum 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, or GenAI-based initiatives in clinical/life sciences.

AI & Technology Fluency: Familiarity with document basics of (Gen)AI, automation tools, or prompts. 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, excellent client-facing communication, experience managing deliverables within large programs, understanding of Agile methodologies, strong stakeholder management, fluency in English, client-first mentality, intense work ethic, collaborative spirit.

How you’ll grow

Cross-functional skills development, custom learning pathways, milestone training programs aligned to career progression, internal mobility paths.

Perks & Benefits

At [Employer hidden — sign up to reveal], your growth matters. We offer a comprehensive total rewards package supporting health, financial future, time away, and professional development. For details on total rewards in Germany, visit ZS Germany office locations.

Hybrid working model

We are committed to giving our employees a flexible and connected way of working. A flexible and connected [Employer hidden — sign up to reveal] allows us to combine work from home and on-site presence at clients/[Employer hidden — sign up to reveal] offices for the majority of our week.

Travel

Travel is a requirement at [Employer hidden — sign up to reveal] for client facing [Employer hidden — sign up to reveal]ers; business needs of your project and client are the priority.

Considering applying?

At [Employer hidden — sign up to reveal], we honor diversity and inclusion. Learn more about our inclusion and belonging efforts.

[Employer hidden — sign up to reveal] is an equal opportunity employer. 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, is required. No agency calls, please.

Find Out More At: www.zs.com

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