Medical Coding Mgr
在 Eisai,满足未得到满足的医疗需求和增加医疗保健为患者，他们的家人和护理人员提供的好处是 Eisai 的人类健康保健 (hhc) 任务。我们是一个不断增长的制药公司，在神经学和肿肿瘤学领域突破了发展。我们的历史包括开发许多创新性药物，特别是发现世界上最广泛使用的阿尔茨海默病治疗方法。随着我们继续扩大，我们正在寻找高动机人士想要工作在快速环境中并产生影响。如果这是你的个人资料，我们希望听到你的话。医疗编码经理通过使用 MedDRA 和世卫组织药物词典对临床团队进行副作用，随时的药物和其他数据点编码/记录来为临床团隊提供医学编码专业知识。该角色审查了在研究中，项目内以及整个项目的准确性和一致性方面编码数据列表，并跟踪了来自 QC 数据评估的问题。医疗编程经理作为临床团伙关于字典和编码相关问题的资源，包括但不限于标准 MedDRA 查询 (SMQ) 和标准药物组合 (SDGs). 该角色参与了研究人员的监督下，在特定兴趣主题中使用词典术语的其他列表 (AESI) 的开发。该职位确保医学编码结果符合研究时间表并遵循全球监管当局要求，并在临床团队代表医疗编码。经理审查研究协议以支持研究设计，数据库构建和利用词典编码计划分析，并有助于制定和维护编码过程文件，例如：编码指南。医疗编码经理通过使用 MedDRA 和世卫组织药物词典编码/记录不良事件，随之伴随的药物和其他数据点为临床团队提供医学编码专业知识。该角色审查了在研究中，项目内以及跨项目的编码数据列表以确定准确性和一致性，并跟踪了临床代表 (s) 在 QC 数据评估中产生的问题上。医疗編码经理作为临床团伙关于字典和编码相关问题的资源，包括：
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At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.If this is your profile, we want to hear from you.
The Medical Coding Manager provides medical coding expertise to clinical teams by coding/recoding of adverse events, concomitant medications and other data points using MedDRA and WHO Drug dictionaries. This role reviews the coded data listings for accuracy and consistency within a study, within a project, and across projects, and follows up with clinical representative(s) as to questions arising from the QC data review.
The Medical Coding Manager acts as a resource to the clinical teams on dictionary and coding related issues including, but not limited to, use of the Standard MedDRA Queries (SMQs) and Standard Drug Groupings (SDGs). This role participates in the development of adverse events of special interest (AESI) listings, and other lists of dictionary terms for use in identifying subjects of interest, under the supervision of a senior group member.
This role ensures medical coding deliverables meet study timelines and follow regulatory authorities’ requirements globally and represents Medical Coding on the clinical teams. The Manager reviews study protocols in order to support the study design, database build and planned analyses utilizing the dictionary coding and contributes to the development and maintenance of coding process documents, e.g. Coding Guidelines.The Medical Coding Manager provides medical coding expertise to clinical teams by coding/recoding of adverse events, concomitant medications and other data points using MedDRA and WHO Drug dictionaries. This role reviews the coded data listings for accuracy and consistency within a study, within a project, and across projects, and follows up with clinical representative(s) as to questions arising from the QC data review.
The Medical Coding Manager acts as a resource to the clinical teams on dictionary and coding related issues including, but not limited to, use of the Standard MedDRA Queries (SMQs) and Standard Drug Groupings (SDGs). This role participates in the development of adverse events of special interest (AESI) listings, and other lists of dictionary terms for use in identifying subjects of interest, under the supervision of a senior group member.
This role ensures medical coding deliverables meet study timelines and follow regulatory authorities’ requirements globally and represents Medical Coding on the clinical teams. The Manager reviews study protocols in order to support the study design, database build and planned analyses utilizing the dictionary coding and contributes to the development and maintenance of coding process documents, e.g. Coding Guidelines.
Essential Functions
- Completes medical coding activities for all study milestones and in support of evolving business practices. Maintains synonym lists to ensure accuracy and consistency of coded data. Participates in data review post dictionary migrations to ensure consistency in the migrated data. Applies GCP principles to medical coding activities following SOPs, SWPs and related guidelines. Ensures coding meets all regulatory authorities’ requirements.
- Consults with medical Study Directors and reviewers to resolve medical coding issues/queries. Participates in SAE coding reconciliation, responding to questions from Data Management and Pharmacovigilance. Provides training relevant to medical coding function to clinical team members as needed, e.g. MedDRA structure, SMQs, WHO Drug.
- Provides input into the development of training materials and job aids. Reviews coding process documents under development.
- Identifies gaps in the coding dictionaries, proposing terms to the group for consideration to be submitted to the dictionary vendors.
- Assists in monitoring the status of the coding tools, reports technical issues that could impact times lines and quality of coding to the head of Medical Coding and/or Data Operations.
Requirements
- Minimum 4 years of coding experience using MedDRA and WHO Drug dictionaries in a pharmaceutical or biotechnology company.
- A health care professional with understanding of the pathophysiology of disease.
- In-depth knowledge of MedDRA and WHO Drug Dictionaries.
- Prior experience with Central Coding, InForm; additional: dsNavigator or other coding applications.
- Ability to work with minimal supervision in a team environment.
- Excellent oral and written communication.
- Knowledge of industry best practices, regulatory requirements and GCP.
- Ability to build successful relationships with cross-functional team members.
- Embracing and contributing to our culture of process improvement with a focus on streamlining processes and adding value.
- A Bachelor's degree or higher in a life science e.g. Nursing, Pharmacy or in lieu of a degree, equivalent licensure and significant experience in an allied health care field.
- Data Management and/or Pharmacovigilance experience is a plus.
Eisai Salary Transparency Language:
The annual base salary range for the Medical Coding Mgr is from :$99,900-$131,100Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit .
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status.Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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Originally posted on Himalayas