Medical Coder – Contract

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the primary coding resource for designated clinical trials

• Develop and uphold Medical Coding Guidelines as well as Serious Adverse Event reconciliation plans with sponsors

• Conduct medical coding utilizing WHODrug and MedDRA dictionaries

• Assess coding accuracy and consistency, which includes the approval of coded terms and synonym lists

• Reconcile serious adverse events among clinical trial databases, safety systems, and other relevant sources

• Create coding and SAE queries as needed

• Work in collaboration with safety, clinical, and data management teams to address discrepancies

• Record coding decisions and rationales for audit purposes

• Support the maintenance of coding tools, including the creation and execution of UAT scripts

• Engage in MedDRA and WHODrug dictionary versioning workflows

• Evaluate coding tools and implement coding/SAE listings in elluminate

• Ensure adherence to company and industry quality standards, regulations, guidelines, and procedures

• Execute additional responsibilities as assigned

⛳️ Requirements

• Bachelor’s degree in a relevant health science or a professional qualification in a pertinent scientific/technical discipline is preferred

• Over 5 years of experience in the Pharmaceutical/Biotechnology sector with medical coding expertise using WHODrug and MedDRA is preferred

• Familiarity with industry standards, ICH guidelines, and regulatory requirements concerning medical coding

• Comprehensive understanding of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methods

• Outstanding verbal and written communication abilities

• Detail-oriented with strong skills in multitasking, prioritization, planning, and organization

• Capability to work both independently and collaboratively within a team

🏝️ Benefits

• Remote work options

• Work-life balance

• Opportunities for learning, growth, and continuous improvement

• An inclusive culture that values diversity

• Equal opportunity employment