About The Position

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.

Requirements

  • 3+ years of experience in pharmaceutical research, biotech research, drug discovery, translational science, clinical development, regulatory affairs, CMC, pharmacovigilance, HEOR, or academic biomedical research.
  • Background 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 pharmacovigilance.
  • Familiarity 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 systems.
  • Comfort 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 summaries.
  • Strong analytical thinking and written communication skills.
  • Ability to translate pharmaceutical R&D workflows into clear, structured task documentation.

Nice To Haves

  • Experience in pharma, biotech, academic medical centers, clinical research organizations, regulated R&D environments, or major biomedical research programs.
  • Familiarity with IND, NDA, BLA, EMA submissions, CMC documentation, clinical trial operations, pharmacovigilance, HEOR, real-world evidence, or DMC materials.
  • Experience preparing or reviewing study protocols, investigator brochures, pharmacology reports, biomarker analyses, CMC technical reports, regulatory drafts, or clinical development documentation.
  • Industry fellowship training, clinical research certification, regulatory affairs certification, or related specialized training is helpful.
  • Strong attention to detail in scientific, regulated, and documentation-heavy research environments.

Responsibilities

  • Review pharmaceutical research scenarios involving target identification, medicinal chemistry, biology workflows, high-throughput screening, DMPK, PK/PD, toxicology, and biomarker analysis.
  • Evaluate research materials against source documents, study requirements, experimental rationale, data outputs, and documented scientific criteria.
  • Support structured review of pharmacology reports, biomarker analyses, preclinical documentation, translational research materials, and lab workflow records.
  • Identify missing assumptions, documentation gaps, scientific inconsistencies, and expected research review outcomes.
  • Review clinical development scenarios involving study protocols, investigator brochures, Phase I–IV materials, clinical operations workflows, statistical outputs, and study documentation.
  • Evaluate clinical materials against required sections, source materials, study objectives, endpoint definitions, and operational requirements.
  • Support structured review of DMC briefing documents, clinical study reports, protocol summaries, clinical operations files, and study-related documentation.
  • Prepare clear written explanations for clinical development decisions based on source materials and verifiable criteria.
  • Review regulatory and CMC scenarios involving IND, NDA, BLA, EMA materials, CMC technical reports, quality documentation, safety materials, and submission workflows.
  • Support structured review of real-world evidence, HEOR, pharmacovigilance, regulatory affairs, and CMC documentation.
  • Work with materials connected to platforms such as Medidata Rave, Oracle Clinical One, Schrödinger Suite, MOE, Benchling, LabArchives, or similar pharma R&D systems.
  • Maintain accuracy, consistency, and professional judgment across submitted work.

Benefits

  • Competitive hourly compensation
  • Flexible scheduling
  • Part-time commitment
  • Weekly payments via Stripe or Wise
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