Associate Director -- Medical Safety Officer , Oncology

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Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description:

POSITION SUMMARY:

Johnson and Johnson Innovative Medicine (JJ IM) Associate Medical Safety Officer (aMSO) has accountability for assessing the medical safety of assigned Janssen products and will work closely with an experienced Medical Safety Officer to strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight and represent Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.

The aMSO will work under the supervision of an experienced MSO and will report to the GMS Therapeutic Area Safety Head (TASH) or Senior Director Product Safety Head and oversee the safety and benefit/risk assessment of assigned products within the Hematology TA that are marketed and/or in clinical development. Collaborating with relevant functions, the aMSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit-risk assessment of assigned products within the TA. The aMSO will communicate potential and known risks and changes to benefit/risk, when appropriate, to the experienced. MSO, Senior Director Product Safety Head, TA Safety Head, the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer (CSO), JJ Innovative Medicine Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) JJ IM, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the aMSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products.

Principal Responsibilities

Working closely with an experienced MSO

·         Execute on the Global Medical Safety organization’s strategy, by implementing programs and leading in the strategic priority areas as defined by the Chief Safety Officer

·         Serve as a subject matter expert in the therapeutic area and patient risk management throughout the product life cycle

·         Lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS), as well as other activities related to managing the safety profile of assigned products (e.g., Product Safety Strategy, Program Safety Analysis Plan)

·         Build collaborative partnerships with other GMS groups and functional stakeholders including, but not limited to Clinical TA, Non-Clinical Safety, Global Epidemiology, Regulatory Affairs, Biostatistics, and Medical Affairs

·         Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams

·         Anticipate safety concerns and influence other relevant functions including Clinical and Medical Affairs teams to minimize/mitigate patient impact by active participation in the design of protocols.

·         Be an active partner and core contributor of safety input to key regulatory or clinical documents including: 

o    Risk management plans

o    Clinical Trial, EAP and IIS Protocols

o    Informed Consent Forms (ICF), including Risk Language

o    Safety Sections of Investigator’s Brochure (IB) and IB adde