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24-MAG

Remote | Pharmaceutical Research & Development Consultant — $65–$90/hour

24-MAG

4h ago

No Phone Required$135k - $187kOtherUnited Stateshimalayas
Pharmaceutical-ResearchDrug-Discovery-ConsultingClinical-DevelopmentRegulatory-AffairsBiotech-ConsultingRemote-Senior-Chemistry-ConsultantRemote-Consultant-PharmacistRemote-Clinical-Research-SpecialistPharmaceutical-ConsultantRemote-Regulatory-Affairs-SpecialistDrug-Development-ConsultingSenior

Job Description

We are sharing a specialised part-time consulting opportunity for professionals experienced in pharmaceutical research, drug discovery, translational science, clinical development, regulatory documentation, CMC workflows, and structured pharma R&D processes.This role supports current and upcoming remote consulting opportunities focused on structured pharmaceutical research review, clinical development workflow analysis, regulated R&D documentation, study protocol assessment, biomarker and pharmacology review, regulatory materials, and high-quality project execution. Selected professionals will apply their pharma, biotech, or academic research expertise to review realistic R&D scenarios, evaluate documentation requirements, prepare structured written outputs, and support accurate, evidence-based pharmaceutical research workflow tasks.Key ResponsibilitiesProfessionals in this role may contribute to:Drug Discovery & Translational Research ReviewReview pharmaceutical research scenarios involving target identification, medicinal chemistry, biology workflows, high-throughput screening, DMPK, PK/PD, toxicology, and biomarker analysisEvaluate research materials against source documents, study requirements, experimental rationale, data outputs, and documented scientific criteriaSupport structured review of pharmacology reports, biomarker analyses, preclinical documentation, translational research materials, and lab workflow recordsIdentify missing assumptions, documentation gaps, scientific inconsistencies, and expected research review outcomesClinical Development & Study DocumentationReview clinical development scenarios involving study protocols, investigator brochures, Phase I–IV materials, clinical operations workflows, statistical outputs, and study documentationEvaluate clinical materials against required sections, source materials, study objectives, endpoint definitions, and operational requirementsSupport structured review of DMC briefing documents, clinical study reports, protocol summaries, clinical operations files, and study-related documentationPrepare clear written explanations for clinical development decisions based on source materials and verifiable criteriaRegulatory, CMC & R&D Workflow SupportReview regulatory and CMC scenarios involving IND, NDA, BLA, EMA materials, CMC technical reports, quality documentation, safety materials, and submission workflowsSupport structured review of real-world evidence, HEOR, pharmacovigilance, regulatory affairs, and CMC documentationWork with materials connected to platforms such as Medidata Rave, Oracle Clinical One, Schrödinger Suite, MOE, Benchling, LabArchives, or similar pharma R&D systemsMaintain accuracy, consistency, and professional judgment across submitted workIdeal ProfileStrong candidates may have:3+ years of experience in pharmaceutical research, biotech research, drug discovery, translational science, clinical development, regulatory affairs, CMC, pharmacovigilance, HEOR, or academic biomedical researchBackground in one or more areas such as target identification, medicinal chemistry, biology, HTS, DMPK, PK/PD, toxicology, biomarkers, clinical development, biostatistics, clinical operations, regulatory affairs, CMC, real-world evidence, or pharmacovigilanceFamiliarity with pharma R&D tools and platforms such as Medidata Rave, Oracle Clinical One, Schrödinger Suite, MOE, Benchling, LabArchives, electronic lab notebooks, clinical data systems, or related research systemsComfort reading and preparing pharma research artifacts such as study protocols, investigator brochures, IND/NDA/BLA materials, pharmacology reports, biomarker analyses, CMC reports, DMC briefing documents, and research summariesStrong analytical thinking and written communication skillsAbility to translate pharmaceutical R&D workflows into clear, structured task documentationEducational BackgroundPhD, MD, PharmD, or master's degree in pharmaceutical sciences, biomedical sciences, biology, chemistry, pharmacology, medicine, biostatistics, regulatory affairs, clinical research, or a related field is helpfulEquivalent practical experience in pharmaceutical research, clinical development, translational science, regulatory documentation, or biotech R&D workflows is also highly relevantNice to HaveExperience in pharma, biotech, academic medical centers, clinical research organizations, regulated R&D environments, or major biomedical research programsFamiliarity with IND, NDA, BLA, EMA submissions, CMC documentation, clinical trial operations, pharmacovigilance, HEOR, real-world evidence, or DMC materialsExperience preparing or reviewing study protocols, investigator brochures, pharmacology reports, biomarker analyses, CMC technical re