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Friday, December 13, 2013

F/T - Sr. Regulatory Info Spec't, Novartis (NJ)

Senior Regulatory Information Specialist, Novartis Pharmaceuticals – NJ

Novartis Institutes for BioMedical Research (NIBR) is currently seeking a Senior Information Specialist to primarily conduct literature searches in order to assist in researching, preparing and submitting regulatory submission reports.

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

Minimum Requirements:

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

• 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

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

To apply: