PT/Temp) Information Specialist, Pro Libra Assoc. – NJ
Our client, a major pharmaceutical company is seeking a
part time, Information Specialist to primarily conduct literature
searches in order to assist in researching, preparing and submitting
regulatory submission reports. This position is located in Northern New
Jersey. Application Deadline is January 31, 2014.
Main Responsibilities:
• To support the Regulatory Information Management functions particularly with the Drug Safety teams.
• Partner with Brand Safety Leaders to understand the needs of the therapeutic area products regulatory reporting.
• Create search strategies for PSURs, DSURs, class effects, and other regulatory obligations, or requests from Health Authorities.
• Proficient in OvidSP/Medline and Embase in order to perform clinical and nonclinical literature searches
• Work with Regulatory Information Administrators to execute and perform quality control for results and final reports.
• Advanced bibliographic expertise in searching and managing information
Education and experience:
• Master of Library & Information Science or similar education
• BS in a biomedical science, advanced degree preferred
• 2-3 years of work experience in a corporate (pharmaceutical, technical or medical) Information Center
• Proven talent to work independently & excellent interpersonal and communication skills
• Experience with technical services procedures using Windows-based computer systems, databases and electronic resources
• Keen understanding of the drug regulatory process such as NDA/IND/Periodic Safety Update annual reporting processes
Skills:
• Ability to prioritize and deliver results across multiple projects, good project management skills
• Professional attitude and service orientation with ability to communicate and consult with core customer base.
• Demonstrate proven ability to positively impact project goals and directions
• Proficient with scientific, medical and business information resources; experience in expert searching Medline, Biosis, and Embase mandatory
To discuss further please contact:
Angela C. Dzikowski, VP, CPC, CTS
Pro Libra Associates Inc 800-262-0070 908-918-0077 908-918-0277 Fax adzikowski@prolibra.com
Main Responsibilities:
• To support the Regulatory Information Management functions particularly with the Drug Safety teams.
• Partner with Brand Safety Leaders to understand the needs of the therapeutic area products regulatory reporting.
• Create search strategies for PSURs, DSURs, class effects, and other regulatory obligations, or requests from Health Authorities.
• Proficient in OvidSP/Medline and Embase in order to perform clinical and nonclinical literature searches
• Work with Regulatory Information Administrators to execute and perform quality control for results and final reports.
• Advanced bibliographic expertise in searching and managing information
Education and experience:
• Master of Library & Information Science or similar education
• BS in a biomedical science, advanced degree preferred
• 2-3 years of work experience in a corporate (pharmaceutical, technical or medical) Information Center
• Proven talent to work independently & excellent interpersonal and communication skills
• Experience with technical services procedures using Windows-based computer systems, databases and electronic resources
• Keen understanding of the drug regulatory process such as NDA/IND/Periodic Safety Update annual reporting processes
Skills:
• Ability to prioritize and deliver results across multiple projects, good project management skills
• Professional attitude and service orientation with ability to communicate and consult with core customer base.
• Demonstrate proven ability to positively impact project goals and directions
• Proficient with scientific, medical and business information resources; experience in expert searching Medline, Biosis, and Embase mandatory
To discuss further please contact:
Angela C. Dzikowski, VP, CPC, CTS
Pro Libra Associates Inc 800-262-0070 908-918-0077 908-918-0277 Fax adzikowski@prolibra.com
