Clinical Research-Technical /Medical Writer - (Summit, NJ)

Position title :Clinical Research-Technical /Medical Writer Job Id :3582 Location :Summit NJ USA 07901 Duration :6+Months This position has a key role to assist the global clinical development, regulatory, and safety to continually assess and analyze clinical safety signal data and inform key stakeholders to implement strategies to minimize risk and proactively partner with global health authorities. This position includes interactions with all areas within clinical development, medical affairs, independent review committees, and regulatory authorities to ensure timely identification, reporting, and response to health authorities with regards to safety issues. Responsibilities include, but are not limited to, the following: Assist the Clinical Research Teams in the development and analysis of safety data trends and events of special interest. Monitor SPM events for assigned programs, participate in reconciliation and preparation for Safety Management Committee reviews.