Engineering Lead – Medical Writing (Clinical Research) - Contract Position

We are looking for an Engineering Lead to build and run the technology platform behind clinical and regulatory medical writing. You will lead a team of engineers that automates and speeds up how documents such as protocols, Clinical Study Reports (CSRs), Investigator's Brochures and CTD Module 2 summaries get written, reviewed and submitted. That includes structured content authoring, data-to-text generation and validated generative AI

Must have 13+ years in software engineering, 4+ years leading teams, 8+ years in life sciences clinical research

Technical leadership and architecture

• Own the architecture and roadmap for the medical writing platform: authoring, content reuse, review and approval, and submission publishing.
• Design modular, structured content (component-based authoring) so text blocks, tables and figures are reused across protocols, CSRs, IBs, patient narratives, lay summaries and CTD Modules 2.5/2.7.
• Build data-to-document pipelines that turn SDTM/ADaM datasets and TLFs (tables, listings, figures) into draft CSR sections and patient narratives.
• Set engineering standards for code quality, security, cloud architecture, API design and observability.

Integration and data

• Integrate authoring tools with document management (e.g. Veeva Vault RIM/Submissions, Documentum), CTMS, EDC, statistical computing environments and the eTMF.
• Build APIs and event-driven workflows for document lifecycle, assignments, review rounds and e-signatures.
• Support eCTD publishing and validation, including PDF rendering, bookmarks, hyperlinks and regional requirements (FDA, EMA, PMDA, Health Canada).

Compliance and validation

• Make sure systems meet GxP, 21 CFR Part 11, EU Annex 11, GAMP 5 and Computer Software Assurance (CSA) expectations.
• Own the validation lifecycle with QA: requirements, risk assessment, IQ/OQ/PQ or CSA testing, traceability matrices and change control.
• Apply data privacy and security controls (HIPAA, GDPR, de-identification and anonymization of clinical documents for CTR/EU CTR and Health Canada PRCI disclosure).

People and delivery

• Hire, mentor and manage engineers; run Agile/Scrum ceremonies, sprint planning and code reviews.
• Turn medical writers' pain points into a prioritized backlog with product owners and writing leads.
• Report delivery status, risks, budget and adoption metrics to senior stakeholders.
• Manage vendors and evaluate third-party authoring and AI tools (build vs. buy).

Generative AI and automation

• Lead design and delivery of LLM-based drafting assistants, such as protocol-to-CSR carryover, TLF summaries, narrative generation, plain-language summaries and QC checks.
• Build retrieval-augmented generation (RAG) over approved sources: protocols, SAPs, prior submissions, style guides and regulatory guidance.
• Put in place guardrails: human-in-the-loop review, source traceability for every generated statement, hallucination checks, prompt and model versioning, and evaluation benchmarks.
• Automate document QC: data-vs-text consistency, cross-reference and abbreviation checks, template and style conformance, and ICH E3 structure checks.

• Bachelor's or Master's degree in Computer Science, Engineering, Bioinformatics, Life Sciences or a related field.
• 13+ years of software engineering experience, including 4+ years leading engineering teams or programs.
• 8+ years building or supporting systems for pharma, biotech, CROs or medical devices, ideally in clinical development, regulatory or medical writing.
• Hands-on skill in at least one backend language (Python, Java or C#/.NET) and a modern front-end framework (React or Angular).
• Experience delivering LLM or NLP solutions to production: prompt engineering, RAG, embeddings, evaluation and monitoring.
• Strong cloud experience (AWS, Azure or GCP), including containers, CI/CD and infrastructure as code.
• Working knowledge of clinical documents and standards: ICH E3 (CSR), ICH E6(R3) GCP, ICH M4 (CTD), CDISC SDTM/ADaM and TLF outputs.
• Experience delivering validated systems under GxP, 21 CFR Part 11 and GAMP 5 / CSA.
• Clear communicator who can explain technical trade-offs to medical writers, statisticians, regulatory and QA teams.

• Prior work at a top-20 pharma company, a large CRO (e.g. IQVIA, ICON, Parexel, Syneos, PPD) or a regulatory-tech vendor.
• Delivered a GenAI medical writing tool used in live submissions, such as CSR drafting, narrative automation or lay summaries.
• Knowledge of TransCelerate Common Protocol Template (CPT), the ICH M11 structured protocol, and CDISC USDM / Digital Data Flow.
• Familiarity with regulatory AI guidance: FDA draft guidance on AI for regulatory decision-making, EMA reflection paper on AI, and the EU AI Act.
• Experience with clinical trial transparency: EU CTR redaction, Health Canada PRCI, EMA Policy 0070 anonymization.
• Certifications: AWS / Azure Solutions Architect, PMP or SAFe, Certified Scrum Master, or AMWA / EMWA membership.