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Manager/Associate Director Medical Coding in Bernards, NJ at DSI

Date Posted: 4/28/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!
With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
Job Summary
The Manager / Associate Director, Medical Coding manages the end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize medical coding processes, technology, and standards. This position ensures quality delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding dictionary ensuring all clinical trials meets quality requirements and best practices in medical coding. Serves as a subject matter expert for medical coding.
Responsibilities:
Leadership, Direction, and Strategy:
  • Provides medical coding expertise and guidance to the project team regarding the medical coding activities and deliverables. Ensures deliverables meet/exceed project/study team expectations regarding quality, time, and cost.
  • Establishes medical coding strategy at the project and/or study level for a larger number of projects/studies with greater complexity.
  • Ensures medical coding deliverables for all studies within the project/program level meets quality, time, and cost effective
  • Develop and lead medical coding processes and procedures and ensure consistency across programs and organization
  • Proactively identifies and manages risks at the project and/or study level for a larger number of projects/studies with greater complexity.
  • Interact with global counterparts in Japan and Europe to ensure consistency of coding procedures and guidelines
  • May manage medical coding full-time and/or contract staff.
Project Management:
  • Plans and directs the conduct of medical coding activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).
  • Provides oversight to CRO pertaining to medical coding, coding standards, and coding library management.
  • Manages, reviews and approves medical coding of clinical data ensuring high quality; creates and manages the synonym-lists to ensure accuracy and consistency of the coded data, and adherence to regulatory authorities’ requirements.
  • Ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
Functional Expertise:
  • Serves as a subject matter expert in medical coding
  • Reviews/approves clinical study related documents pertaining to medical coding and coding conventions including synonym documents.
  • Provides coding expertise in the development, implementation and evaluation of coding conventions and synonym standards document.
  • Interfaces with colleagues from study teams across therapeutic areas on coding-related matters. Consults with Study Directors and/or Medical Monitors to resolve medical coding issues/queries.
  • Participates in SAE coding reconciliation as necessary.
Operational Efficiency / Continuous Improvement:
  • Provides leadership within Data Management related to medical coding topics by partnering with internal and external stakeholders to optimize medical coding and library management.
  • Develop and maintain coding and dictionary management processes for Daicchi-Sankyo in collaboration with key stakeholders.
  • Leverages comprehensive Data Management and medical coding expertise to promote best practices across the Clinical Trial lifecycle.
  • Applies GCP principles to ensure all medical coding activities follow global SOPs, SOIs, and associate guidelines.

Qualifications:
Education
  • BS, BSN or MS degree
Experience
  • Manager: 5+ years of experience / Associate Director: 8 + years of experience in a medical or pharmaceutical company, or similar environment (e.g. CRO)
  • 5 + years coding experience, minimum of 3 years coding oncology indications (Solid tumor and hematological indications preferred)
  • 3+ years combined experience managing people and/or initiatives
Competencies
  • Familiar with reporting tool Spotfire or J-Review
  • Proficiency in medical coding, strong knowledge of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I-IV)
  • Experience overseeing vendors performing clinical trial and/or medical coding
  • Experience in developing and maintaining coding processes and conventions
  • Strategic thinker, risk assessment and mitigation
  • Strong negotiation, team building and conflict resolution
  • Excellent communication and interpersonal skills
  • Familiar with EDC preferably Medidata RAVE
  • Familiarity with coding and clinical trial data management system preferably Medidata RAVE coder
Compensation and seniority level/title will be commensurate with experience and qualifications. Duties and responsibilities may vary based on the position level/title.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran statu