Job Description

Integrated Data Analytics and Reporting (IDAR)
Analyst II Medical Coder*
(*Title may vary based on Region or Country requirements)Position Summary:
The Analyst II Medical Coder assists in the provision of multi-functional support in coding governance and associated processes. This position will be responsible for enabling the provision of consistent, accurate and reproducible coding of clinical study data, and ensure adherence to established J&J R&D coding processes and guidelines. The Analyst II Medical Coder will contribute to global thesaurus and code list maintenance, along with the maintenance and enhancement of dictionary encoding products and systems. This position reports to Medical Coding Functional Leadership and represents Data Management in multi-functional discussions.
Principal Responsibilities:

• Provide oversight of IDAR data coding activities to ensure adherence to Regulatory Authority and Industry standards for coding practices and processes.
• Execute and promote adherence to established coding governance activities and principles.
• Support delivery of consistent, accurate and reproducible coding of clinical trial data meeting individual project timelines.
• Share knowledge of coding processes and coding encoding systems with cross-functional partners.
• Address cross-functional and cross-sectoral coding inquiries and data coding issues.
• Participate in continuous improvement initiatives contributing to innovation and the maturation of an industry leading data acquisition and coding capability.
• Actively contribute to the shaping of the organization, improving re-usability, efficiency, and consistency of coding tools and processes across studies and therapeutic areas.
• Contribute to global thesaurus and code list maintenance, along with the maintenance and enhancement of dictionary encoding products, systems, and processes.
• Exhibit solid problem solving and decision-making skills with input and support from more senior coding colleagues.

Principal Relationships:

• Reports into people manager position within functional area (e.g., Head Medical Coding).
• Functional contacts within IDAR include but not limited to: Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations.
• Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to: Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human

Resources and Project Coordinators.

• External contacts include but not limited to: External partners and suppliers, CRO management and vendor liaisons, industry peers and working groups.Education and Experience Requirements:

Required

• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD).
• Approx. 5 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• Proven knowledge of industry standard coding thesauri (MedDRA, WHO Drug) and the ability to utilize and contribute to the maintenance of incumbent dictionary encoding products and systems.
• Experience working in a multi-functional environment and ability to adapt to different ways of working.
• Excellent written and verbal communications skills (in English).

Preferred

• Understanding of the overall drug development process and GCP/ICH guidelines.
• Innovative thinking to support design and execution of medical coding strategies.

Other:

• Approx.

eQuest