Senior Medical Coder

Macrogenics Rockville , MD 20850

Posted 1 week ago

Overview

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.

Qualifications

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

Supervisory Responsibilities

No

Preferred Qualifications

  • Advanced degree

  • Knowledge of RAVE EDC

  • Oncology therapeutic area experience

Statement

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 info@macrogenics.com 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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Medical Data Review Manager RRG (R1056222)

Iqvia Holdings Inc

Posted 4 days ago

VIEW JOBS 5/19/2019 12:00:00 AM 2019-08-17T00:00 Job Description Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. PURPOSE Provide expert skills as part of a Medical Data Review team to provide efficient, quality Medical Data Review products that meet customer needs. RESPONSIBILITIES * Serves as a Subject level Data reviewer (SLDR) and Identify any anomalies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy * Conducts in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data). * Ensures data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. * Defines data capture requirements in line with protocol and reporting needs. * Provide project management to the team in the area of Project Management and viewed as an expert in data management. * Drive the delivery of end-to-end study data quality and integrity * May act as a clinical data scientist for performing data analytics by reviewing the visualizations, identify potential issues of concern and present at multi-disciplinary team meetings and external meetings Provide medical, clinical, and scientific advisory expertise. * Maintain strong customer relationships. * With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions. * Ensure timely follow-up and resolution of compliance issues. * Serve as Subject Matter Expert (SME). * Serve as POC/ Back-up POC. * Continuously looks for opportunities to improve efficiency of tasks and quality of deliverables. * Provide therapeutic area/indication training for the project clinical team. * Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Good understanding of clinical/medical data. * Proven expertise in the proactive identification of issues. * Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics. * Proven ability to work within a matrix team environment requiring minimum level of supervision Attention to detail * Interpersonal and analytical skills * Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology. * Must have Medical but also an operational focus towards metrics and status information to take the appropriate actions to resolve. * Excellent communication, interpersonal, customer service, and teamwork skills. Page 2 * Excellent organizational and problem-solving skills. * Excellent project management skills and coaching skills. * Ability to work with minimal supervision, using available resources. * Ability to work on multiple projects and manage competing priorities. * Strong customer focus skills. * Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Medic with 5 year college degree or MBBS; or Bachelor's degree in clinical, biological, mathematical sciences, or related field, or nursing qualification, with 7 years of relevant work experience; or equivalent combination of education, training and experience . Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled' We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™ Job ID: R1056222 Apply Now Not ready to Apply? CHECK OUT OUR SIMILAR JOBS * Clinical Research Associate Jobs * Researcher Jobs * Jobs in Washington, District of Columbia * Clinical Research Associate Jobs Washington, District of Columbia Iqvia Holdings Inc Rockville MD

Senior Medical Coder

Macrogenics