Zimmerman Associates inc
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MedDRA Coder, Validator
at Zimmerman Associates inc
The qualified candidate will review and analyze regulatory documents containing medical adverse events and apply MedDRA codes to classify the event. The candidate will be responsible for the following duties and functions:
- Review and analyze adverse events and determine the appropriate medical MedDRA code
- Perform research and retrieve information to address stakeholder inquiries and resolve problems
- Provide suggestions and recommendations on improving system- and coding-related procedures
- Train other team members in MedDRA coding practices and assist other team members resolve complex issues, provide feedback to help improve quality of project deliverables
- Contribute to the development of manuals, guides, SOPs, and presentations
- Interface and collaborate with internal and external stakeholders
Additionally, the qualified candidate will have:
- Proven knowledge and experience in ICH/MedDRA terminology, codes, and principles
- Excellent oral and written communication skills
- Interface with internal users as well as external stakeholders.
- BS Degree (MS preferred) in a medically license profession
- Minimum of 3 years experience in a medical or scientific field
- At least 2 years of management/supervisory experience
- Proficient use of computers and experience using Excel spreadsheet as an analysis and reporting tool
- Ability to prepare management, business, technical, and personnel reports, reviews, and documents for internal and external use
- Excellent verbal and written communication skills
- Excellent interpersonal skills
- Ability to lift and carry 35 pounds
- Ability to walk and stand for long periods during workday
- Preferred: Minimum of one (1) year experience in Government (management)
- Preferred: Quality Assurance experience
Education: A Bachelor’s Degree from an accredited university or college in a related field such as Business Administration or Management.
Clearance: MUST HAVE SECRET (required)
ZAI is an equal opportunity employer. In compliance with Federal and State Equal Opportunity Laws, qualified applicants are considered for all positions applied for without regard to race, color, religion, sex (including pregnancy and gender identity) , national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, veterans status or any other legally protected status.