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About Micro1: Job DescriptionRole Title: Regulatory Affairs SpecialistRole Type: ContractorLocation: Remotemicro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.Scope of WorkAuthor and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.Preferred Qualifications5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).

About Micro1: Job DescriptionRole Title: Pharmacovigilance ExpertRole Type: ContractorLocation: Remotemicro1 is engaging Pharmacovigilance Experts to contribute their advanced drug safety expertise on a key customer project. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters. This opportunity is ideal for professionals experienced in authoring and reviewing complex safety reports, passionate about data quality, and committed to clear written and verbal communication.Scope of WorkAuthor and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data and case-level records.Apply expert judgment to assess the accuracy and adequacy of interval safety findings, signal evaluations, and benefit-risk conclusions in alignment with best practices.Assess template and structural conformity to ICH E2F and ICH E2C requirements, including proper section content, presentation of cumulative versus interval data, and completeness of appendices.Reconcile figures and case counts across report sections and data sources, identifying and documenting discrepancies significant for regulatory review.Evaluate safety conclusions in light of new data or events, and provide clear, structured written rationales supporting your determinations.Deliver structured feedback to inform the development of AI-driven tools for pharmacovigilance documentation and analysis.Preferred Qualifications5+ years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.Demonstrated proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit-risk assessment methodology.Hands-on experience with MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level information.Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, MD, MSc, or equivalent).Experience in both development-stage and post-marketing safety reporting, QPPV or deputy QPPV roles, safety committee participation, or AI-assisted safety review tools is a plus.

About Micro1: Job DescriptionRole Title: Clinician (Oncology / Hematology)Role Type: ContractorLocation: Remotemicro1 is engaging Clinician (Oncology / Hematology)s to contribute to a customer’s project at the forefront of AI in healthcare. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.Scope of WorkAuthor and review evaluation tasks that require nuanced clinical judgment, leveraging Clinical Study Reports, periodic safety reports, and regulatory correspondence in oncology and haematology.Assess the clinical defensibility of efficacy and safety conclusions, ensuring endpoints and effect sizes reflect true clinical significance.Apply advanced judgment to dose escalation, dose-limiting toxicity, modifications, adverse event grading and attribution, and the coherence of patient narratives.Evaluate benefit-risk reasoning, scrutinizing the durability of conclusions in light of new events, and the realism of described management strategies.Identify and flag content that is clinically implausible or internally inconsistent, distinguishing these from legitimate clinical variation.Provide structured, guideline-based written rationales that clearly explain the validity or limitations of clinical interpretations for a non-clinical audience.Preferred QualificationsSpecialist registration or board certification in medical oncology and/or haematology, with 5+ years of post-training clinical experience.Direct involvement in clinical trials as investigator, sub-investigator, or sponsor-side medical monitor, safety physician, or clinical development physician.Proficiency with CTCAE grading, relevant response criteria (RECIST, Lugano, IMWG, IWCLL, ELN), and outcome endpoints (ORR, DoR, PFS, OS, MRD).Hands-on experience with trial documents such as protocols, investigator brochures, CSRs, safety narratives, or DSMB/IDMC materials.Demonstrated excellence in written communication, with clear, structured explanations of clinical reasoning tailored for non-clinical readers.Previous roles in medical monitoring or as medical director on oncology or haematology programmes, and committee participation (IDMC, DSMB, adjudication, or independent review committees).Peer-reviewed publication record or authorship on clinical trial manuscripts, with any exposure to AI-assisted clinical review tools seen as a plus.

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About Micro1: Job DescriptionRole Title: Bankruptcy AttorneyRole Type: ContractorLocation: Remotemicro1 is engaging Bankruptcy Attorneys to contribute their specialized legal expertise to a customer's innovative project. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.Scope of WorkAnalyze, review, and annotate legal documents specific to bankruptcy law, providing expert feedback and substantive commentary.Draft sample motions, pleadings, and court filings reflecting common and complex scenarios in bankruptcy proceedings.Evaluate hypothetical legal scenarios and deliver well-reasoned written explanations and argumentation.Contribute to the creation of educational content and model training datasets relevant to bankruptcy practice.Assess model-generated legal answers for accuracy, clarity, and alignment with current U.S. bankruptcy law.Participate in written and verbal communications, ensuring precise, high-quality input for AI training purposes.Identify nuances and emerging trends in bankruptcy law that can enhance the project's quality and breadth.Preferred QualificationsJuris Doctor (JD) degree from an accredited U.S. law school.Active license to practice law in the United States, with a minimum of 3 and up to 15 years of recent, hands-on bankruptcy law experience.Direct experience as an independent contributor on bankruptcy matters, including filings, court appearances, and advisory work.Strong written and verbal communication skills, with a demonstrated ability to explain intricate legal concepts clearly and concisely.Judicial clerkship experience, particularly for a bankruptcy or federal judge (preferred).Experience teaching law (e.g., adjunct or guest lecturer) or creating legal instructional materials (preferred).Editorial experience with a legal journal or law review during law school (preferred).