Job Summary

Position Description

•       Contribute as a part of the Risk Management Plan group within the regulatory writing group

•       Participate in the development, writing, and management of Risk Management Plans (RMPs) including EU-Risk Management Plans (EU-RMPs) and local RMPs for drug and biologic products

•       Write and prepare RMPs documents, including EU-RMPs

•       Ensure all RMPs are prepared with high quality and according to regulatory requirements

•       Organize and lead comment review meetings

•       Represent the regulatory writing group in cross functional team meetings for RMPs

Requirements

•       Ability to read and analyze scientific and medical literature

•       Knowledge of global pharmacovigilance risk management regulations and guidance

•       Experience with writing of regulatory submission documents (eg, periodic safety updates, Core Technical Documents, briefing documents, RMPs, etc.)

•       Excellent analytical and problem solving skills

•       Excellent Project Management Skills

•       Excellent oral and written communication and interpersonal skills

•       Ability to work with interdisciplinary teams

POSITION NOTE: Please login to your Virtual Vocations account to view the company information and application instructions