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Micro1

3 weeks ago
N/A
Remote
$140 - $200/hour

About Micro1: Job DescriptionRole Title: AI Domain ExpertRole Type: Contractor (Part Time)Location: Remotemicro1 is engaging AI Domain Experts to contribute to a high-impact project that advances artificial intelligence. 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 WorkReview and critically assess AI-generated outputs for accuracy, logic, and alignment with best practices in your field.Design and refine prompts that challenge AI reasoning and reflect realistic scenarios relevant to your domain.Deliver clear, concise, and constructive written feedback to improve AI model responses and performance.Evaluate and annotate data with keen attention to detail, helping to build robust datasets for model training and validation.Conduct quality reviews on AI outputs, documentation, and feedback provided by other experts.Collaborate remotely with a diverse, global community of professionals, sharing insights to foster ongoing learning and improvement.Uphold ethical standards in AI development through careful analysis and thoughtful critique.Preferred Qualifications3+ years of experience in fields such as Software Engineering, Finance, Data Science, or Legal, with a proven record of producing exceptional written work (e.g., technical documentation, investment memos, legal memoranda, research papers, or strategy presentations).Outstanding written English with the ability to articulate complex analyses, deliver nuanced feedback, and communicate clearly in a remote setting.Demonstrated critical thinking and analytical skills, with experience reviewing, critiquing, or editing high-stakes documents.Strong attention to detail, professional writing ability, and adaptability when facing evolving project requirements.Experience working independently and collaboratively within remote or distributed environments.Backgrounds from leading technology companies, top consulting firms, elite financial institutions, premier law firms, or world-renowned universities are highly valued but not required.Exposure to data annotation, prompt engineering, or AI output evaluation is an advantage, though not essential.

Data annotation Prompt engineering Critical thinking +8 more
3 weeks ago
N/A
Remote
$50 - $80/hour

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
3 weeks ago
N/A
Remote
$80 - $100/hour

About Micro1: Job DescriptionRole Title: STEM AI Agent Research SpecialistRole Type: ContractorLocation: Remotemicro1 is engaging STEM AI Agent Research Specialists to contribute to a customer's advanced AI training 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 engagement focuses on reviewing and analyzing historical session traces from local or agentic AI tools used in rigorous STEM research or technical problem-solving. Strong written and verbal communication skills are essential, as you will assess, document, and articulate technical processes and insights for project deliverables.Scope of WorkReview, curate, and submit historical session traces from local or agentic AI tools (e.g., Claude Code, Claude Cowork, Codex, Claude for Life Sciences, OpenCode) demonstrating substantive STEM research or technical workflows.Analyze and validate the technical depth and integrity of AI-assisted problem-solving, ensuring sessions involve multi-step reasoning and authentic human guidance.Document research methodologies, problem-solving approaches, and points of human intervention within session traces.Evaluate the effectiveness and limitations of agentic AI tools in STEM research contexts, highlighting areas for improvement or model training.Produce clear, concise written explanations outlining session processes, outputs, and validation steps.Provide constructive feedback on the AI’s performance, accuracy, and reasoning based on professional STEM experience.Important: This role requires hands-on experience using local agentic AI tools to support STEM workflows (e.g., research, coding, analysis, experimentation, or technical problem-solving). Candidates without practical experience using these tools may not be a strong fit for this project.Preferred QualificationsAdvanced academic or professional background in a STEM field (science, technology, engineering, or mathematics).First-hand experience using local or agentic AI tools for research or technical projects, beyond web-based chatbots.Access to and familiarity with historical session data involving STEM or technical workflows.Strong skills in scientific reasoning, technical research, data analysis, code debugging, and research documentation.Demonstrated ability to guide, challenge, and validate AI-generated outputs within complex problem-solving scenarios.Excellent written and verbal communication skills for clear technical documentation and feedback.Experience with AI evaluation, output validation, and iterative research methods is highly valued.

Stem research Agentic ai Technical research +14 more
3 weeks ago
N/A
Remote
$50 - $70/hour

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).

Regulatory affairs Ich guidelines Ctd/ectd structure +4 more
M

Micro1

3 weeks ago
N/A
Remote
$70 - $80/hour

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

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