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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, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Cardiopulmonary to be located in Raritan, NJ; Titusville, NJ or Horsham, PA.

The Pharmaceuticals Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned Janssen products and will strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.

The MSO will report to the GMS Therapeutic Area Safety Head (TASH), Cardiopulmonary TA and oversee the safety and benefit/risk assessment of assigned products within the Cardiopulmonary TA that are marketed and/or in clinical development. Collaborating with relevant functions, the MSO 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 MSO will communicate potential and known risks and changes to benefit/risk, when appropriate, to the TA Safety Head, the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the MSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products.

Responsibilities include, but are not limited to the following:

• Strategically 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., Program Safety Analysis Plan)

• 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 the 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 (CSR)

  • 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

• 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 Pharmaceuticals Medical Safety Council (MSC)

• Actively participate and contribute to meetings with Health Authorities and external key opinion leaders

• Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities

• Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products. This will include:

  • Defining the safety question or issue requiring medical safety assessment

  • Developing the strategy for the safety review and analysis

  • Interpreting results and determining the medical importance of question or issue

  • Reviewing and approving (i.e., signatory) medical assessment reports, e.g. ad hoc safety reports

• Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues

• Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management

• Lead or actively participate in department-wide initiatives

Education and Experience:

• Physician (MD or equivalent), generally requires 2-5 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

• Demonstrated 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 highly 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:

• Ability to effectively and strategically lead global cross-functional teams

• 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

• 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

The anticipated base pay range for this position is $194,000 to $334,650.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company’s long-term incentive program.

• Employees are eligible for the following time off benefits:

  • Vacation – up to 120 hours per calendar year

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

  • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found via the following link: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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