形容
Janssen Research & Development, LLC, is recruiting for a Medical Safety Officer, Cellular Therapy to be located in Titusville, NJ; Raritan, NJ; Horsham, PA or Allschwil, Switzerland. Remote work options may be considered on a case-by-case basis and if approved by the Company.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC. discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo .
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
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), Cellular Therapy and oversee the safety and benefit/risk assessment of assigned products within the Cellular Therapy 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.
- 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.
- 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.
- Lead or actively participate in department-wide initiatives.
資格
Education and Experience:
- Physician (MD or equivalent) with a minimum of 2 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs)
- Board Certification (if US) preferred
- Cellular Therapy or Bone Marrow Transplant clinical or industry experience preferred
- Medical specialization (Hematology-Oncology) 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 $186,000 to $322,000.
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.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .