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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical coding for clinical trials, ensuring compliance with ICH guidelines and industry standards while effectively managing coding quality and documentation. Proficient in utilizing MedDRA and WHO Drug Dictionaries, with strong communication and organizational skills to support cross-departmental collaboration.
Highest-signal resume keywords
Medical Coding Using MedDRAMedical Coding Using WHO Drug DictionaryKnowledge of ICH/GCP GuidelinesExperience in Pharmaceutical/Biotechnology IndustryProficiency in Microsoft Office Applications
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical CodingData ReviewCoding GuidelinesClinical Data ManagementData Warehouse Tools
Soft Skills
Excellent Communication SkillsDetail OrientedMultitaskingTeam PlayerStrong Organizational Skills
Tools & Technologies
VeevaMedidata RAVE CoderElluminateCORE
Industry Keywords
Clinical TrialsCRO EnvironmentPharmaceutical IndustryBiotechnology IndustryRegulatory Compliance
About the role
Key responsibilities & impact- Ensure accurate and consistent coding of medical data for clinical trials
- Take ownership of scientific operations deliverables, applying expertise to complex challenges
- Independently review data coded by third parties to ensure consistent coding
- Oversee outsourced CRO work through medical coding review and synonym dictionary review
- Review and maintain guidance and training documentation for coding guidelines in accordance with ICH guidelines and dictionary definitions
- Support other departments concerning dictionary use and coding quality
- Collaborate on creation and maintenance of CDM documents referencing coding-related activities
- Support and manage MedDRA and WHO Drug Dictionary upversion activities, including third-party vendor-operated studies
- Ensure compliance with industry quality standards, regulations, guidelines and procedures
Requirements
What you’ll need- A degree in nursing, biology or health-related field
- English fluency
- 5+ years medical coding using MedDRA and WHO Drug Dictionaries
- 5+ years in Pharmaceutical/Biotechnology industry or CRO environment
- Knowledge of ICH/GCP guidelines and methodology
- Excellent verbal and written communication skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
- Excellent team player
- Proficiency in Microsoft Office Applications
- Working knowledge of MedDRA and WHO Drug best practice documents
- Experience with coding application(s), Veeva and Medidata RAVE Coder desirable
- Experience with data warehouse tools (ie. Elluminate, CORE)
- Good understanding of Clinical Data Management processes and the applicable regulatory requirements
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways