Drug Listing Tech II Job in North Wales 19436, Pennsylvania Us
JOB DESCRIPTION:
Overview:
Teva Pharmaceuticals USA is the leading generic pharmaceutical company, marketing products from a wide range of therapeutic areas including analgesic, anti-infective, cardiovascular, oncology, CNS, dermatological and anti-inflammatory. Teva USA products are marketed to chains, wholesalers, distributors, hospitals, managed care entities, and government agencies. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals.
Responsibilities:
Position Summary : The drug listing technician is responsible for the preparation, validation and submission of Drug Listing in accord with 21 CFR Part 207; Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing; Structured Product Labeling (SPL) and Electronic Submissions Gateway (ESG).
Travel Requirements: Infrequent domestic travel required. Less than 5% of time to local facilities.
Essential Duties Responsibilities Percentage of Time
1
With some guidance prepare SPL COL/DL submissions using current software and submit through the FDA ESG. Correspond directly with FDA SPL personnel.
75
2
Assist in the training of other technicians.
10
3
Actively participate on SPL Drug Listing Teleconferences.
10
4
Update databases as needed.
5
5
Other projects and duties as required/assigned
Qualifications:
Position Requirements
Education Required:
Associates Degree, or equivalent combination of education and experience.
Education Preferred
Bachelors Degree
Experience Required:
Minimum 2 years electronic document creation and word processing experience.
Experience Preferred:
Previous experience in pharmaceutical regulatory affairs and/or labeling/proofreading. Strong organizational skills. Knowledge of injectable products is preferred.
Specialized or Technical Knowledge Licenses, Certifications needed:
Proficient in Microsoft Office, Adobe Acrobat, Oracle and A4L i4i SPL R4.
Physical Requirements Frequency
1.
Able to sit for extended periods of time
Frequent
2.
Able to use general office and telecommunications equipment
Continuous
3.
Capable of meeting Teva's employee attendance requirements
Continuous
Search Firm Representatives Please Read Carefully:
Teva is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.
All resumes submitted by search firms to any employee at Teva via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Teva. No fee will be paid in the event the candidate is hired by Teva as a result of the referral or through other means.
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