MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Senior Medical Coder is responsible for the strategy and execution of coding activities across multiple MacroGenics clinical trials and ensures that all applicable regulatory policies (e. g., ICH, CFR) and industry best practices are in place for the day-to-day operational support of coding activities. This is a hands-on non-supervisory position responsible for ensuring quality medical coding deliverables in a timely fashion. Ensures coding standardization across studies.
Responsibilities and Job Duties
Codes medical condition and medication verbatim terms collected in MacroGenics' clinical trials using MedDRA and WHO-DDE.
Ensures verbatim terms are specific enough to allow clear, appropriate and complete coding according to MacroGenics established coding guidelines and conventions.
Initiates queries and/or clarification requests to investigational sites, Product Safety, or Data Management when additional information is required to properly code verbatim terms. Ensures satisfactory resolution.
Facilitates dictionary updates in the EDC database and updates coding accordingly.
Provides support to Medical Safety Physicians/Monitors for coding review (e. g., adverse events, medical history, concomitant medications).
Represents the coding function on project/study teams and work collaboratively to coordinate/communicate with management and other team members regarding clinical coding activities for study status, task and timeline updates.
Reviews coding performed by other coders and other third-party vendors (e.g., Contract Research Organizations), when applicable, to ensure coding uniformity, accuracy, and consistency
Mentors and trains more junior coders, when applicable.
Writes, revises, reviews new or existing coding-related SOPs, work instructions, forms, and templates.
Manages all assigned studies including coding resource planning and timelines.
Supports the development and delivery of training to MacroGenics and study site personnel on coding and dictionary related activities.
Keeps abreast of coding related industry and regulatory development in the Biopharmaceutical industry.
Other duties as assigned by manager.
Education, Experience & Credentials
Bachelors in life sciences or health related field with 6 years of relevant experience, or an advanced degree with 4 years of relevant experience
Knowledge, Skills & Abilities
Excellent knowledge of coding dictionaries (e. g., MedDRA, WHO Drug) and medical terminology.
Previous experience coding in an EDC system (e. g., Medidata Rave, Inform, Oracle Clinical TMS).
Strong knowledge of regulations, guidelines and initiatives (e.g., FDA, EU, EMA, ICH) and industry best practices related to Clinical Medical Coding.
Strong written and verbal communication skills.
Strong interpersonal and organizational skills
Knowledge of RAVE EDC
Oncology therapeutic area experience
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service. Equal Opportunity Employer/Veterans/Disabled
For more information about our commitment to equal employment opportunity, please click here.