Some opportunities happen only once in a lifetime – like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
The Senior Manager (SM) of Medical Coding is responsible for overseeing medical coding, creating and improving internal coding guidelines and processes, and managing medical dictionaries. SMs work within the clinical data management function and operate cross-functionally with medical monitors, clinical scientists, safety specialists, and vendor coding teams to ensure accurate and consistent coding for clinical data deliverables. SMs ensure that high-quality coded data are delivered to support data analyses for regulatory submissions, safety monitoring, and publications.
You will be responsible for:
- Performing quality oversight of external vendor’s coding performance, including coding accuracy and documentation preparation and control.
- Assisting with creating and reviewing medical coding standard operating procedures and work instructions.
- Collaborating with stakeholders regarding coding status, including expeditiously escalating issues to senior leaders and resolving medical coding issues with the global safety team.
- Managing coding dictionary versions, dictionary support documentation, and the up versioning of coded terms as applicable while adhering to industry-standard coding practices and company-wide standardized MedDRA and WHO Drug coding guidelines.
- Developing and generating data listings for coding in collaboration with vendors.
- Assisting with user acceptance testing (UAT) for internal and outsourced studies to ensure the coding tool is working as expected before the study go-live.
- Assisting with the development, maintenance, and documentation of items on medical coding, including but not limited to global coding guidelines, coding decision logs, internal and vendor-related coding reports, and up versioning documentation.
- Proactively identifies potential study issues/risks, recommends solutions, and participates in developing and implementing process improvements to support the collection, coding, integration, monitoring, review, and reporting of coded data.
You will need to have:
- Experience in medical coding in the CRO, pharmaceutical, or biotechnology industry for 5+ years.
- A Bachelor’s degree in a life science or health-related field.
- Expertise with MedDRA and WHO Drug coding dictionaries.
- Experience in medical coding in the pharmaceutical/biotechnology industry covering Phase I-IV studies with working knowledge of coding tools (i.e., Medidata RAVE Coder, TMS, ARGUS, etc.).
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Extensive knowledge of medical terminology.
- Solid understanding of ICH and regulatory environment pertaining to data management and medical safety.
- Solid knowledge of regulatory requirements for the conduct of medical coding in global trials.
- Some experience with EDC databases coding data for rare disease clinical trials.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees.
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