СШАSolution Scientist
1 нед. назад
131k–187k USD / годСШАSeniorRemote
regulatory documentationr&d documentationproduct implementationworkflow design
Technical product lead bridging engineering and domain experts to implement systems for biopharma R&D documentation management.
О компании
- At , we build tools that help biopharma companies create and manage their R&D documentation in a fraction of the time. If you’re looking to join a team whose mission is to fundamentally change the way that drug development gets done, we’d love to talk to you.
- We’re growing very fast, and we’re looking for a domain-expert technical product lead —someone with a strong pharma background who can sit between engineering teams and end users, help implement our system in real customer environments, and translate deeply technical capabilities into workflows that actually make sense to scientists, medical writers, and regulatory teams.
- This is not a traditional product manager role, nor a traditional medical writing role. It’s a hybrid: part domain architect, part technical translator, part customer-facing problem solver.
Обязанности
- As a core member of ’s product team, you will act as the bridge between engineering and domain experts.
- Your primary responsibility will be to help design, implement, and evolve systems that generate and manage regulatory and R&D documentation—particularly in the non-clinical and/or CMC domains—by ensuring that domain reality is faithfully represented in the pro
- duct.
Требования
- 3+ years of experience in medical writing, regulatory affairs, or a closely related pharma role
- Direct experience drafting, reviewing, or overseeing CTD content (especially non-clinical)and/or CMC)
- Strong understanding of regulatory expectations across FDA, EMA, and ICH
- Experience working cross-functionally with regulatory, scientific, and technical stakeholders
- Strong written and verbal communication skills
- Ability to analyze workflows and extract rules, patterns, and constraints
- Comfort reviewing structured or semi-structured system outputs (including AI-generated content)
- Ability to communicate clearly with engineers and product teams
- Willingness to be customer-facing and support implementation
- and feedback loops
- Familiarity with structured data formats (XML, JSON) is a plus
- Experience working with life sciences software tools is a plus
- Ability to operate independently in a fast-moving startup environment
Другое
- End users: (medical writers, regulatory professionals, scientists) to understand how documents are actually authored, reviewed, and quality-controlled in pr actice
- Engineering teams: to translate those workflows, constraints, and edge cases into system behavior
- Product leadership: to shape feature scope, prioritization, and release readiness
- You will help explain how the system works to users, collect feedback on where it breaks down, and communicate those insights back to engineering in a way that is precise, actionable, and technically useful.
- This role is about systems, not just documents.
- You will:
- Deconstruct how regulatory and R&D documents are authored, reviewed, and QC’d in real organizations
- Translate domain rules, conventions, and preferences into clear product and engineering requirements
- Help implement in customer environments and support early adoption
- Evaluate AI-generated outputs for correctness, structure, and regulatory soundness
- Identify gaps, inconsistencies, and edge cases, and work with engineers to resolve them
- Help validate features ahead of release by stress-testing them against real-world
- use cases
- Communicate technical system behavior to non-technical users, and user needs back to engineers
- You’ll work across a wide range of content: CTD modules, internal summaries, briefing packages, templates, and sponsor-facing deliverables. You don’t need to be an expert in every document type on day one, but you do need to learn quickly and explain what you learn clearly.
- This role is ideal for someone who:
- Comes from pharma or biotech and deeply understands regulatory documentation
- Is excited by product design and system thinking , not just writing
- Enjoys acting as a translator between technical and non-technical teams
- Wants to shape how AI systems behave in regulated environments
- Very comfortable working in a fast-paced and intense startup environment
- Willing to work in-person in our office in Mission Bay 4-5 days/week
- Likes matcha KitKats, believes every LLM prompt is just Schrödinger’s cat waiting to be observed, and knows too many random facts about the Mongol postal system