Johnson & Johnson companies are equal opportunity employers.
HEAD OF RISK MANAGEMENT-0507140131
Description
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Head of Risk Management (Senior Director) to be located in Horsham, PA, Titusville, NJ or Raritan, NJ.
Janssen Research & Development, L.L.C. is a fully integrated biopharmaceutical and biotechnology company. As a world leader in the field of biomedicines, Janssen strives to develop innovative treatments to improve the health of people worldwide. At the forefront of monoclonal antibody technology and manufacturing, Janssen Research & Development manufactures products including REMICADE® (infliximab), STELARA™ (ustekinumab) and SIMPONI™ (golimumab) for the treatment of various immunological diseases.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Head of the Risk Management (RM) Group will report to the EU QPPV for Janssen Pharmaceuticals, and will be responsible for the overall supervision and strategic direction of the RM Group. The Head of RM will oversee a staff of scientists and physicians, and will provide strategic direction on all matters pertaining to risk management. The RM Group will provide both scientific and operational support for Safety Management Teams (SMT), as well as strategic advice on developing optimum risk management strategies, including risk mitigation activities for all Janssen Pharmaceuticals products, whether marketed or in development. The RM Group will also act as a strategic resource for the J&J enterprise, providing advice and working collaboratively with leaders in the Consumer and MD&D sectors to define the best risk management strategies for all J&J products.
The Head of the RM Group will participate in the activities of the QP office and ensure the proactive consideration of risk management strategy in all areas of GMO. The Head will also be responsible for working closely with each of the GMO functional heads, particularly Medical Safety Assessment and GMS Operations, including International PV staff. In addition, The Head will be responsible for working with other key Janssen R&D stakeholders, including but not limited to regulatory affairs and medical affairs, to ensure the appropriate implementation of risk management strategies and activities into a seamless global risk management system.
The Head of the RM Group will ensure ongoing assessment and evaluation of changes to risk management regulations and legislation globally, thereby enabling the organization to anticipate and implement changes to the company risk management system in a timely manner. In addition, the Head will engage with key external stakeholders, academic institutions and/or regulatory bodies to ensure that J&J actively participates in and possibly lead the shaping of the external risk management landscape.
The Head of the RM Group will have clear, strategic decision-making responsibilities with respect to the overall design and cross-functional implementation of the Janssen risk management system.
Qualifications
An MD with 10 or more years of Pharmaceutical, Consumer, or Medical Device Industry experience including at least 5 years of pharmacovigilance experience is required. Proven track record in leading and implementing global risk management strategy is required. Demonstrated in-depth 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 is preferred. Proven track record in dealing with difficult safety issues and clinical safety data is required. Interactions with domestic and international regulatory departments / agencies is preferred. Strong collaborative and networking skills is required. Ability to successfully manage multiple critical issues simultaneously, critically evaluate data from multiple sources (e.g., clinical trials, post-marketing environment, literature), and assess the strategic importance of the data is required. Management experience in supervising a group of employees is required. Proven leadership skills; ability to thrive in a global, matrix environment is required. The ability to influence, negotiate and communicate with both internal and external customers is required. The ability to develop, implement, communicate, and influence policy and strategy internally and externally to the company is required. Excellent verbal and written communication skills, including formal presentation skills is required. Written skills as evidenced by publication and journal articles also desirable. This position will be based in Horsham, PA, Titusville, NJ or Raritan, NJ. There will be up to 10% domestic and international 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-Horsham
Other Locations:North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan
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
HEAD OF RISK MANAGEMENT-0507140131
Description
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Head of Risk Management (Senior Director) to be located in Horsham, PA, Titusville, NJ or Raritan, NJ.
Janssen Research & Development, L.L.C. is a fully integrated biopharmaceutical and biotechnology company. As a world leader in the field of biomedicines, Janssen strives to develop innovative treatments to improve the health of people worldwide. At the forefront of monoclonal antibody technology and manufacturing, Janssen Research & Development manufactures products including REMICADE® (infliximab), STELARA™ (ustekinumab) and SIMPONI™ (golimumab) for the treatment of various immunological diseases.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Head of the Risk Management (RM) Group will report to the EU QPPV for Janssen Pharmaceuticals, and will be responsible for the overall supervision and strategic direction of the RM Group. The Head of RM will oversee a staff of scientists and physicians, and will provide strategic direction on all matters pertaining to risk management. The RM Group will provide both scientific and operational support for Safety Management Teams (SMT), as well as strategic advice on developing optimum risk management strategies, including risk mitigation activities for all Janssen Pharmaceuticals products, whether marketed or in development. The RM Group will also act as a strategic resource for the J&J enterprise, providing advice and working collaboratively with leaders in the Consumer and MD&D sectors to define the best risk management strategies for all J&J products.
The Head of the RM Group will participate in the activities of the QP office and ensure the proactive consideration of risk management strategy in all areas of GMO. The Head will also be responsible for working closely with each of the GMO functional heads, particularly Medical Safety Assessment and GMS Operations, including International PV staff. In addition, The Head will be responsible for working with other key Janssen R&D stakeholders, including but not limited to regulatory affairs and medical affairs, to ensure the appropriate implementation of risk management strategies and activities into a seamless global risk management system.
The Head of the RM Group will ensure ongoing assessment and evaluation of changes to risk management regulations and legislation globally, thereby enabling the organization to anticipate and implement changes to the company risk management system in a timely manner. In addition, the Head will engage with key external stakeholders, academic institutions and/or regulatory bodies to ensure that J&J actively participates in and possibly lead the shaping of the external risk management landscape.
The Head of the RM Group will have clear, strategic decision-making responsibilities with respect to the overall design and cross-functional implementation of the Janssen risk management system.
Qualifications
An MD with 10 or more years of Pharmaceutical, Consumer, or Medical Device Industry experience including at least 5 years of pharmacovigilance experience is required. Proven track record in leading and implementing global risk management strategy is required. Demonstrated in-depth 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 is preferred. Proven track record in dealing with difficult safety issues and clinical safety data is required. Interactions with domestic and international regulatory departments / agencies is preferred. Strong collaborative and networking skills is required. Ability to successfully manage multiple critical issues simultaneously, critically evaluate data from multiple sources (e.g., clinical trials, post-marketing environment, literature), and assess the strategic importance of the data is required. Management experience in supervising a group of employees is required. Proven leadership skills; ability to thrive in a global, matrix environment is required. The ability to influence, negotiate and communicate with both internal and external customers is required. The ability to develop, implement, communicate, and influence policy and strategy internally and externally to the company is required. Excellent verbal and written communication skills, including formal presentation skills is required. Written skills as evidenced by publication and journal articles also desirable. This position will be based in Horsham, PA, Titusville, NJ or Raritan, NJ. There will be up to 10% domestic and international 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-Horsham
Other Locations:North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan
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