Job Information
Otsuka America Pharmaceutical Inc. Senior Clinical Coding Specialist in Charleston, West Virginia
Job Summary
Otsuka is a healthcare company driven by our purpose and defined by our beliefs. Otsuka DM is part of the Clinical Analytics department and supports the efficient and effective development and delivery of the clinical pipeline. The Sr. Clinical Coding Specialist represents the OPDC Data Management Department in a leadership role as a key member of the Global Medical Coding Working Group to govern global medical coding practices. The Sr. Clinical Coding Specialist also provides technical expertise to coders, data managers, and project teams to develop and maintain consistency, accuracy and quality of data coding.
Job Description
Lead and manage end to end coding activities and deliverables across multiple projects.
Serve as Coding Subject Matter Expert (SME) from protocol review to database lock to provide guidance for all dictionary related issues and strategies.
Collaborate with global Otsuka affiliates to manage the up-versioning and recoding activities of all clinical data according to Otsuka up-versioning strategy.
Maintain, up-version and distribute global synonym lists for clinical data.
Provide consultation, leadership, and expertise to Contract Research Organization (CRO) personnel and internal Data Managers on coding processes.
Maintain OPDC coding guidelines, updating as necessary with input from clinical and safety team members.
Develop standard processes to be used for coding activities.
Establish and maintain training documents related to coding practices.
Work collaboratively with Information Technology team to maintain and upgrade existing coding technology, as well as evaluate new coding applications as needed.
Provide expert review for Testing and Validation documents (eg. User Acceptance Test) as they relate to coding activities.
Attend MedDRA and WHO Drug User group meetings to maintain currency with industry standards and perspectives.
Proactively identify and implement opportunities for process improvements.
Provide input in the development of departmental and global standard operating procedures (SOPs) and Working Practices (WPs).
Review coding listings from CROs for consistency and appropriate assignment of codes.
Provide resolution alternatives to data managers, reviewers and CROs for appropriate coding, based on assessment of industry coding and research.
Collaborate with Clinical Development and Pharmacovigilance for review of coding listings.
Coordinate with Biostatistical Programming and Data Management personnel to resolve coding related issues.
Review Data Management Plans and approve Data Coding Conventions for CROs for OPDC trials as they pertain to clinical coding.
Ensure consistency and accuracy of data coding across programs.
Ensure completion of coding deliverables in accordance with timelines. Provide support in the development of CMQ’s and CDQ’s when requested by Pharmacovigilance, Global Clinical Development or Biostatistics.
Other tasks as assigned.
Qualifications/ Required
Extensive knowledge and skill in developing customized MedDRA queries (CMQs) and WHODrug Customized Drug Groupings (CDGs)
Extensive knowledge and skill of coding with MedDRA and WHO Drug Dictionaries
Ability to read, understand and interpret medical records and other treatment documentation
Knowledge of medical and clinical practices with an understanding of medical concepts and terminology
Solid knowledge of applicable U.S. regulatory requirements and a complete understanding of pharmaceutical industry practices
High level of interpersonal, problem solving, and analytic skills
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs
Basic knowledge and understanding in working with sFTP file sharing systems
Demonstrated knowledge in basic Clinical Data Management standard practices and functionality in clinical drug development
Ability to establish and maintain collaborative working relationships with others
Capacity to remain flexible, frequently re-assessing and re-prioritizing projects based on business needs
Strong oral and written communication and presentation skills
Strong attention to detail, problem solving and critical thinking skills
Ability to exercise independent judgment in the decision-making process
Travel (approximately 20%)
Educational Qualifications
Bachelor’s degree or Master’s Degree (preferred) with a minimum 6 years of clinical trial coding experience working in pharmaceutical industry or CRO
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Minimum $121,103.00 - Maximum $181,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
Application Deadline : This will be posted for a minimum of 5 business days.
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .
Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
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