US-NJ, Global Risk Management Plan Manager 232814BR-MZ
Global Risk Management Plan Manager
Global Develop NPH
East Hanover, NJ
Research & Development
Work closely with the BSL and the designated medical writer for the timely preparation, development and finalization of high quality and regulatory compliant global drug safety Risk Management Plans (RMP) for small and large scale pharmaceutical projects by interpreting the efficacy and safety data. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Develop the Risk Management Plan (RMP) regulatory strategy in collaboration of the Brand Safety Leader (BSL) for the preparation and submission of the RMP for new products. Direct the preparation of RMP section by discussing the efficacy and safety data for the Health Authorities agency. Provide regulatory guidance to departments/ development project cross-functional teams for the writing of the RMP document according to regulatory Affairs policies. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards in the system Rosetta Phoenix . Communicate worldwide regulatory requirements for drug registration and clinical drug development to large cross-functional teams and ensure that the information is interpreted correctly. Provide expertise to medical safety physicians in the management, coordination, development, review, and tracking for the drug related Safety Risk Management plans. Ensure that Safety Risk Management Plans are properly implemented so that all documents are of the highest quality, regulatory compliance using Medical/Scientific writing and verbal skills, and that logistics and distribution activities are handled in an appropriate and timely manner. Track Health Authorities (HA) feedback and assessment on RMP and ensures HA requirements are implemented as required (e.g. in individual RMP, in global RMP template). Review the RMP to ensure consistency and regulatory compliance of RMP sections and annexes in PleaseReview system. Provide Document management system xEDI expertise required for the finalization of the RMP and its annexes. Resolve issues as they arise. Ensures all RMP documents are final in Document management system xEDI . Provide guidance and training for product-specific implementation of RMP commitments and commitment tracking on global and local levels. Provide continuous support to CPOs for all questions/ issues they arise (i.e. facilitates process and communication to Global Program Team regarding RMP questions/issues). Deliver training on updated for RMP regulatory and RMP internal policy.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any 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.
Candidate must have a Masters or foreign equivalent degree in Pharmacy, Chemistry, or Pharmaceutical Sciences and at least 2 year industry experience in drug safety, clinical research, or regulatory affairs. Must have: proven experience and working with large cross-functional teams on large scale pharmaceutical projects; experience in global regulatory requirements for drug registration and/or clinical drug development; experience in quality, efficacy or safety data presentation relating to multiple therapeutic areas; solid experience in Medical/Scientific writing. #LI-DNI
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