About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

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.

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.

You will be responsible for:

• Overseeing and contributing to data coding activities to ensure adherence to Regulatory Authority and Industry standards for coding practices and processes.
• Executing end-to-end coding processes, including Medical Coding Specifications, Terms of Interest, coding quality reviews, and sign-off activities and principles.
• Supporting delivery of consistent, accurate and reproducible coding of clinical trial data meeting individual project timelines.
• Sharing knowledge of coding processes and coding encoding systems with cross‐functional partners.
• Addressing cross‐functional and cross‐sectoral coding inquiries and data coding issues.
• Participating in continuous improvement initiatives contributing to innovation and the maturation of an industry leading data acquisition and coding capability.
• Actively contributing to the shaping of the organization, improving re-usability, efficiency, and consistency of coding tools and processes across studies and therapeutic areas.
• Contributing to global thesaurus and code list maintenance, along with the maintenance and enhancement of dictionary encoding products, systems, and processes.
• Exhibiting solid problem solving and decision‐making skills with input and support from more senior coding colleagues.

Education and Experience Requirements
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. 3 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 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. <10% travel (domestic or international) may be required.

Benefits:
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com