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 addenda

o    Safety sections of Clinical Study Reports

o    Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings

o    Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR), Development Safety Update Report (DSUR)

o    Health authority queries

o    Company Core Data Sheets (CCDS), US and EU prescribing information

o    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

DECISION-MAKING AND PROBLEM-SOLVING:

Takes a leadership role in influencing senior management and key stakeholders across the business to achieve strategic goals. Leads others by example in influencing internal and external partners; demonstrates openness and seeks to understand different perspectives; gains the trust of others; asserts personal ideas and opinions using persuasion to influence others; demonstrates excellent negotiation skills. Gathers diverse viewpoints; proactively influences others appropriately across departments, functional areas, and with external partners.

Is viewed as a trusted partner across the business and with internal and external therapeutic area experts; anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances and coalitions. Uses an active network of relationships to achieve goals; fosters teamwork within own department or function, as well as across departments or functions; proactively addresses organizational barriers to enhance team effectiveness; leads the development of productive relationships among senior leaders and across organizational boundaries. Proactively maintains relationships with internal and external business partners across departments and functions; contributes actively to the effectiveness of cross-functional teams; capitalizes on existing structures and procedures for effectively engaging with partners.

EDUCATION & EXPERIENCE REQUIREMENTS:

Education and Experience: 

•              Physician (MD or equivalent), generally requires 0-3 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs)

•              Board Certification (if US) preferred

•              Medical specialization preferred

•              Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience

•              Knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations is preferred

•              Ability to influence, negotiate and communicate with both internal and external stakeholders

•              Experience with Health Authority presentations is preferred.

Required Technical Knowledge and Skills:

•              Connect, collaborate and build consensus across relevant functions

•              Ability to think strategically, has a global mindset, big picture orientation, Ability to see the context of the entire situation, understand implications to the business

•              Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications. 

•              Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans is desirable

•              Able to plan work to meet deadlines and effectively handle multiple priorities

•              Excellent verbal and written communication skills, including formal presentation skills.  Written skills as evidenced by publication and journal articles also desirable

•              Fluent in written and spoken English

•              Proficiency in Word and PowerPoint is desired

Required Skills:

Preferred Skills: