Associate Director -- Medical Safety Officer , Oncology

Johnson & Johnson Innovative Medicine•Horsham, PA

2d•$159,000 - $274,850•Hybrid

About The Position

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.

Requirements

Clinical Operations
Compliance Management
Compliance Risk
Cross-Functional Collaboration
Developing Others
Medicines and Device Development and Regulation
Quality Control (QC)
Research Ethics
Risk Management
Safety Investigations
Safety-Oriented
Serious Adverse Event Reporting
Standard Operating Procedure (SOP)
Surveillance
Tactical Planning
Team Management
Technical Credibility

Responsibilities

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: Risk management plans, Clinical Trial, EAP and IIS Protocols, Informed Consent Forms (ICF), including Risk Language, Safety Sections of Investigator’s Brochure (IB) and IB addenda, Safety sections of Clinical Study Reports, Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings, Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR), Development Safety Update Report (DSUR), Health authority queries, Company Core Data Sheets (CCDS), US and EU prescribing information, Signal Evaluations
Assess product benefit-risk balance and offer medical input in the conduct of Proactive Safety Reviews and the generation of signal evaluations, structured Benefit-Risk Assessments, Health Hazard Evaluations, Product Safety Strategy documents (PSS), and Risk Management Plans and aggregate and other safety reports, including risk categorizations and minimization activities.
Review and provide input on additional risk mitigation strategies, product labeling and internal and customer safety training materials directed to minimize patient risk and reduce adverse treatment outcomes
Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations, when necessary, to the GMS Leadership Team, CMO, and the JJ IM Medical Safety Council (MSC)
Contribute to the planning and preparation of meetings with Health Authorities and external key opinion leaders on important safety topics and risk management strategies
Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management
Actively participate in department-wide initiatives