About Micro1: Job DescriptionRole Title: Medical Writer / Clinical Document AuthorRole Type: ContractorLocation: Remotemicro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical 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 realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.Preferred QualificationsMinimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents — through your expert input, judgment, and real-world experience.
Ich e3 guidelines
Source data verification
Written communication
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.
Pharmacovigilance
Gvp guidelines
Signal management
+5 more
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.
Clinical oncology
Clinical hematology
Ctcae grading
+10 more
About Micro1:
Legal research
Legal drafting
+17
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).
Bankruptcy law expertise
Legal document analysis
Written communication
+1 more