1+ months

Manager, Dictionary Management (Clinical Trials Coding , MedDRA)

Frazer, PA 15084
Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Position Summary: Ensures medical coding activities and deliverables for area(s) of responsibility are completed in line with business requirements and company objectives. Evaluates and approves service level documents related to medical coding activities. Oversees service providers (SP) to perform core dictionary management functions including creation of Medical Coding Plan, coding of medical terminology, peer / quality control review, issuance of coding related queries, resolution of coding issues and performing final coding procedures to ensure quality and on time deliverables. Evaluates and makes recommendations related to inter- and intra-departmental processes in order to identify and implement efficiencies and quality improvement measures.Provides dictionary information support to stakeholders including search criteria for Medical Monitoring Plans, criteria for searching prohibited/stratification medications and assistance with regulatory responses.  Assists with maintenance of internal dictionary systems and provides training and support to stakeholders including MedDRA, WHODrug and data visualization tools. This is an onsite, office based position and not remote. 

Essential Duties & Responsibilities including but not limited to:


1. Serves as medical coding lead for assigned therapeutic area(s) (TA) and ensures coding consistency is maintained for programs of studies within the TA.
2. Collaborates with the Teva Clinical Study Physician (CSP), Statistics and Clinical Programming (CP) on identifying and developing search criteria for Adverse Events of Special Interest that may be included in the Medical Monitoring Plan or for providing responses to regulatory agency questions.
3. Leads, manages and  provides oversight of medical coding tasks outsourced to external vendors and ensures that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory requirements.
4. Serves as the medical coding focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
5. Supports collaboration, communication, coordination and prioritization within the department working in conjunction with stakeholders cross functional areas.
6. Provides input into CRF design for coding domain forms (AE, MH, CM) ensuring quality data collection can be collected in accordance with protocol requirements.  Provides input for eDiary/ePRO content related to collection of coded data, as necessary. Recommends study or program specific guidances for the eCRF Completion Guidelines (CCGs) as needed to ensure consistency and good quality data is reported for coding.
7. Reviews and provides feedback for study bid proposals related to coding activities.  Reviews and approves SP invoicing for coding services within agreed budget. Monitors budget through life of study and provides feedback on change orders as needed.
8. Attends KOM and study team meetings; provides input into the presentations that involve relevant medical coding topics.
9. Assists in maintenance activities for internal coding tools, including version upgrades, synonym tables, algorithms.
10. Assists in improvement, development and maintenance of coding process documents including SOPs and Work Instructions and job aids.
11. Mentors and/or may provide direct supervision to more junior coding staff. provides training to stakeholders and conducts other projects and tasks as assigned.
 

Qualifications

Education Required: RN with Bachelor Degree (BSN) or higher preferred, or Pharmacy degree or PharmD, or equivalent amount of combined educational and work experience is required. Exceptional candidates may be considered with fewer years depending on experience and education. RN is preferred.

Experience Required: Managers require at least eight or more years of clinical trials coding management experience with oversight in a pharmaceutical or clinical research setting using MedDRA and WHODrug dictionaries. experience working with Clinicians needed.

Experience Preferred: Basic knowledge of CDISC/SDTM/Controlled Terminology, standard database variables preferred. Experience using SQL scripts and TOAD software for searching and reviewing data a plus.

Specialized or Technical Knowledge Licenses, Certifications needed:  Experience using and maintaining various coding systems used in the pharmaceutical or clinical research setting, technical  and outsourcing. 

Functional Knowledge: Extensive experience and expertise using MedDRA and WHODrug terminology.  Other industry dictionary terminology knowlege a plus.

Company/Industry Related Knowledge: Understanding of FDA and international regulations and GCP.  Thorough understanding of the drug development process, clinical trial methodology, GCP regulations, coding and data management principles.

Function
Research & Development
Sub Function
Drug Analysis and Formulation
Reports To

Assoc Director Dictionary Management, Clinical Trial Data Sciences

Tevas Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Categories

Posted: 2019-06-28 Expires: 2019-09-11

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Manager, Dictionary Management (Clinical Trials Coding , MedDRA)

Teva Pharmaceuticals
Frazer, PA 15084

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