Johnson & Johnson companies are equal opportunity employers.
Medical Safety Officer, Immunology-3724140811
Description
Janssen Research & Development (JRD), a member of the Johnson & Johnson Family of Companies, is recruiting for a Medical Safety Officer located in Horsham, PA, Spring House, Pa or Titusville, NJ.
JRD develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, oncology, infectious disease, diabetes, metabolic disorders, and immunologic disorders.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Medical Safety organization and has accountability for assessing the Medical Safety of products or product families and the reasonable mitigation of risk associated with such products. The MSO will report to and assist the Global Medical Safety Therapeutic Area (TA) Safety Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The MSO will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The MSO will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Head of Medical Safety Assessment (MSA), 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 contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen Research & Development, LLC products.
The Medical Safety Officer provides medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff including 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) for medical assessment reports, e.g. ad hoc safety reports, and providing end-to-end (Phase 1 through product life cycle) safety support and surveillance.
The MSO will chair a multidisciplinary Safety Management Teams (SMT) for assigned products whose 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. S/he will participate on TA Clinical Development Teams (CDTs) and Clinical Teams (CTs) as deemed necessary by the TA Safety Head, present medical safety and risk management evaluations as necessary to the CMO, the GMS Senior Leadership Team, and the Pharmaceuticals Medical Safety Council (MSC), and participate in HA interactions regarding safety and risk management, both written and verbal. S/he will provide input and review to key regulatory or clinical documents as appropriate to ensure these key safety documents are of high medical and scientific quality. These might include: Clinical Trial Protocols, Safety Sections of Investigator’s Brochure (IB) and IB addenda, Clinical Study Reports (CSR), Annual Safety Reports (ASR), Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings, Periodic Safety Update Report (PSUR), Core Data Sheets (CDS), and Informed Consent Form Risk Template. The MSO will 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, and participate on due diligence teams to evaluate Licensing & Acquisition opportunities.
Qualifications
A physician (MD or equivalent) with 8 + years biopharmaceutical experience is required.
Board Certification is preferred.
Demonstrated skills in clinical medicine and Pharmacovigilance is required.
Demonstrated basic knowledge of principles of drug development, pharmacology, clinical trial methodology and design, and medical monitoring of trials is desired.
Assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations is required.
Ability to influence, negotiate and communicate with both internal and external customers is required.
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 is required.
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 required.
Ability to plan work to meet deadlines and effectively handle multiple priorities is required.
Excellent verbal and written communication skills, including formal presentation skills is required.
Written skills as evidenced by publication and journal articles is desirable. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required.
Proficiency in PowerPoint is desired.
This position is located in Horsham, PA, Spring House, PA or Titusville, NJ.
There is up to 10% travel.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-Pennsylvania-Spring House
Other Locations:North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Drug & Product Safety Science
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Medical Safety Officer, Immunology-3724140811
Description
Janssen Research & Development (JRD), a member of the Johnson & Johnson Family of Companies, is recruiting for a Medical Safety Officer located in Horsham, PA, Spring House, Pa or Titusville, NJ.
JRD develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, oncology, infectious disease, diabetes, metabolic disorders, and immunologic disorders.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Medical Safety organization and has accountability for assessing the Medical Safety of products or product families and the reasonable mitigation of risk associated with such products. The MSO will report to and assist the Global Medical Safety Therapeutic Area (TA) Safety Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The MSO will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The MSO will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Head of Medical Safety Assessment (MSA), 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 contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen Research & Development, LLC products.
The Medical Safety Officer provides medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff including 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) for medical assessment reports, e.g. ad hoc safety reports, and providing end-to-end (Phase 1 through product life cycle) safety support and surveillance.
The MSO will chair a multidisciplinary Safety Management Teams (SMT) for assigned products whose 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. S/he will participate on TA Clinical Development Teams (CDTs) and Clinical Teams (CTs) as deemed necessary by the TA Safety Head, present medical safety and risk management evaluations as necessary to the CMO, the GMS Senior Leadership Team, and the Pharmaceuticals Medical Safety Council (MSC), and participate in HA interactions regarding safety and risk management, both written and verbal. S/he will provide input and review to key regulatory or clinical documents as appropriate to ensure these key safety documents are of high medical and scientific quality. These might include: Clinical Trial Protocols, Safety Sections of Investigator’s Brochure (IB) and IB addenda, Clinical Study Reports (CSR), Annual Safety Reports (ASR), Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings, Periodic Safety Update Report (PSUR), Core Data Sheets (CDS), and Informed Consent Form Risk Template. The MSO will 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, and participate on due diligence teams to evaluate Licensing & Acquisition opportunities.
Qualifications
A physician (MD or equivalent) with 8 + years biopharmaceutical experience is required.
Board Certification is preferred.
Demonstrated skills in clinical medicine and Pharmacovigilance is required.
Demonstrated basic knowledge of principles of drug development, pharmacology, clinical trial methodology and design, and medical monitoring of trials is desired.
Assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations is required.
Ability to influence, negotiate and communicate with both internal and external customers is required.
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 is required.
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 required.
Ability to plan work to meet deadlines and effectively handle multiple priorities is required.
Excellent verbal and written communication skills, including formal presentation skills is required.
Written skills as evidenced by publication and journal articles is desirable. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required.
Proficiency in PowerPoint is desired.
This position is located in Horsham, PA, Spring House, PA or Titusville, NJ.
There is up to 10% travel.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-Pennsylvania-Spring House
Other Locations:North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Drug & Product Safety Science
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement