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

Role overviewWe 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 AIMust have 13+ years in software engineering, 4+ years leading teams, 8+ years in life sciences clinical researchKey responsibilitiesTechnical leadership and architectureOwn 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 dataIntegrate 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 validationMake 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 deliveryHire, 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 automationLead 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.Required qualificationsBachelor'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.Preferred qualificationsPrior 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.