Manager, Clinical Data Coding
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary . Leads the Clinical Data Coding group, directing coders to support assigned studies. Performs clinical coding of medical conditions and therapies for assigned studies, ensuring accurate and consistent MedDRA and WHODRUG codes are associated with each investigator reported verbatim term, querying sites as needed. Responsible for maintenance and upload of coding dictionaries used with Rave Coder. Performs impact analysis and coordinates updates to ensure no data deliverables are jeopardized . Job Duties . Leads/manages synonym review and update processes . Provides input/review of CRF specifications/designs to ensure efficient coding fields, derivations, edit checks are in place to meet protocol requirements . Leads/coordinates synonym and peer-review activities . Represents Coding Group in process improvement initiatives, dictionary updates, and/or system updates . Serves as a Coding SME to the organization, delivering training, updating SOPs/WPs, and responding to questions as called upon . Escalates issues that may impact coding quality/deliverables to the Director, Data Management Operations . Performs accurate/consistent coding, applying standard conventions, creating appropriate synonyms, creating/closing coding-related queries, and interacting with TDMs/CSLs/Medics/others as needed . Manages and assigns clinical coders to meet the needs of each study and ensures that coding is completed in support of all timelines/deliverables . Maintains Coding-related section s of study DMPs or equivalent documents . Troubleshoots coding problems, collaborating with peers, database developers, and/or IT support as needed . Leads Coding dictionary updates, performing impact analysis for each affected study and works directly with study teams to minimize disruption . Represents the Coding Team and the lead for process improvement initiatives, and/or system update efforts . Serves as a Coding SME . Adheres to procedures surrounding retention of data, records, and information for clinical studies . May provide Subject Matter Expert Support for select topics assigned . Requirements . Bachelor degree in life science, chemistry, pharmacy, nursing, or a related field, or equivalent direct coding experience. Must have least 5 or more years of clinical coding experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus . Self directed and comfortable working in teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required. Familiarity with all applicable regulations including . CFR, GCP, and ICH Guidelines. Strong analytical and project mgmt skills. Strong written and oral communication skills required . Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with Medidata Rave Coder a plus. May report to Director or Above . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.