Description

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Global Dictionary Management to join our Data Acquisition and Coding (DAC) team within Integrated Data Analysis and Reporting (IDAR) Data Management. This position can be located in Titusville, NJ; Raritan, NJ; Springhouse, PA; Horsham, PA; High Wycombe, UK; Beerse, Belgium; Leiden, Netherlands; or Allschwil, Switzerland.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

The Associate Director, Global Dictionary Management will join a growing team driving the implementation of data coding strategy and the future e-clinical trial landscape at Janssen R&D. As a key member of the Data Acquisition and Coding Leadership team, you will lead the Janssen Global Dictionary Management team working closely with internal partners and external Data Management suppliers to deliver industry leading coding capabilities. You will be accountable for leading all aspects of the planning, prioritization, and execution of the activities of the Global Dictionary Management team enabling the provision of consistent, accurate and reproducible coding of clinical study data, and ensuring adherence to established Janssen coding processes and guidelines.

As the business owner of coding systems, the Associate Director will be accountable for the oversight, coordination and management of coding systems and thesaurus up-versioning, making decisions that have a direct impact on the data coding success for Janssen, including strategies for coding oversight and governance, and all coding related processes. You will work in an agile, fast paced, highly motivated, team-centric, and evolving data environment. You will apply creative problem-solving skills and knowledge to support R&D innovation and represent the Janssen coding function at external industry working groups, conferences and user groups collaborating closely with thesauri management suppliers.

Principal Responsibilities:

• Set strategy within the coding and dictionary management capability driving operational excellence and innovation, evaluating industry trends and regulatory requirements.
• Lead and coordinate all aspects of coding and dictionary management activities to ensure timely, high quality, consistent and reproducible coding of clinical trial data.
• Influence multi-functional and cross-sectoral decisions related to coding processes and systems aligning with long term business needs.
• Act as the business owner for the content and maintenance of coding and coding system related documentation.
• Develop, document, and implement coding processes coordinating with applicable parties (Data Management CROs, System suppliers etc.).
• Lead all aspects of the maintenance of the Janssen coding system and supporting tools, including synonym lists and thesauri versions, ensuring currency and availability for use.
• Identify, manage, and resolve global coding risks and issues with multi-functional, cross-sector and external partners.
• Ensure delivery of appropriate coding related training to staff of applicable departments, internal and external.
• Recruitment, onboarding, performance management, and development of staff within reporting line.
• Represent the Janssen coding function at external industry working groups, conferences, and user groups.

Qualifications

• A minimum of a Bachelor's degree is required, preferably in Health Sciences or a related scientific discipline.
• A minimum of 6 years of experience within the Pharmaceutical, CRO (Contract Research Organization (CRO)) or Biotech industry is required
• Experience in Clinical Data Coding is required.
• Strong knowledge of clinical data coding practices (including tools and processes) and relevant regulatory guidelines is required.
• Strong knowledge of regulatory guidance documents, such as Good Clinical Practice (GCP)/International Council for Harmonization (ICH) requirements and relevant clinical Research & Development concepts, required.
• Must have excellent communication skills.
• Must have strong influencing and decision-making skills.
• Demonstrated project leadership skills and experience leading teams to successful outcomes is required.
• Experience in staff performance management and people development is preferred.
• Experience collaborating with multi-functional teams in a matrix environment and partnering with stakeholders, customers, and vendors required.
• The ability to cultivate team efficiency and cohesiveness adapting to an evolving organization and business environments is required.
• This position will require up to 10% domestic and international travel.

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.