Johnson & Johnson companies are equal opportunity employers.
Global Medical Affairs Leader, Immunology-0451140128
Description
Janssen Global Services, L.L.C. (JGS) is a legal corporate entity encompassing a unique group of departments/organizations/teams that provide leadership across business critical areas for Janssen, the pharmaceutical companies of Johnson & Johnson. The following groups make up JGS: Global Commercial Strategy Organization, Global Pharmaceutical Communication and Public Affairs; U.S. Pharmaceutical Procurement Group (USPPG); and Pharmaceuticals Group Business Development (PGBD).
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Global Medical Affairs Leader (GMAL), Immunology is responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology TA. He/she will lead the Global Medical Affairs Team and partner closely with Regional Medical TA/product leaders to develop integrated global medical affairs perspectives, strategies and plans. The GMAL will be a member of the Compound Development Teams, the Safety Management Teams and Global Commercial Teams as well as an ad hoc member of the Clinical Team and Global Market Access Team and will be responsible for development of the global medical affairs plan that reflects prioritized regional needs and which are included in the overall Compound Development Plan. In addition, the GMAL will be accountable for the global publications plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for products starting in early development (phase IIA) and through launch of major life cycle management initiatives (earlier or later as needed). The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally. The GMAL, Immunology will represent global medical affairs on the Rheumatoid arthritis Disease Area Stronghold team.
The GMAL will develop global medical affairs strategy and plan for the assigned compounds based on prioritized regional needs, working with the CDT ensures integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing medical affairs global and regional value needs. This individual will provide a single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV. The GMAL is responsible for pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, and coordination of regional activity in these areas. The GMAL will be an active member of the CDT and will lead a global Medical Affairs TA Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one “unified” voice on the CDT. The role will collaborate closely with the regional medical affairs representatives to develop integrated global medical affairs strategies and plans and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions. This individual will be responsible to synchronize input and output of the Med Affairs plan with the strategic and business plan calendars. The GMAL is responsible for the development and execution of the global publication plan as well as review and approval of publications for marketed products and specified compounds in clinical development. The GMAL will manage the ReCAP process (review of all medical affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products. This individual will be responsible to support development of the Company risk management strategy and plan as well as author and review specific sections of the Periodic benefit-risk assessment report for compounds. Perform Medical impact assessments as required. The GMAL is responsible to ensure all global activities follow J&J Compliance principles, eg. Health Care Compliance , etc.
Qualifications
A minimum of a Ph.D or MD degree is required with specialty training and certification in rheumatology or gastroenterology preferred. Extensive clinical and/or pharmaceutical experience in Immunology is required. Experience in rheumatology disease area and an established network with medical experts/opinion leaders in rheumatology and/or gastroenterology is highly preferred. A minimum of 10 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required, with at least five years in the Medical Affairs environment highly desirable. Knowledge of products, both J&J and competitors, in the Therapeutic Area is preferred. A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required. A demonstrated track record of success within Medical Affairs and/or clinical R&D is needed. A global mindset and direct experience in multiple markets, proven ability to partner cross culturally/regionally required. In-depth knowledge of study methodology, study data reviews and analysis is preferred. Excellent knowledge of study execution, benefit risk management and regulatory affairs is preferred. This individual should be highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues within the TA. Proven ability to act as a medical spokesperson for external audiences is required. Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders. Proven track record on ethics and Credo type principles is needed. This role will require 35% travel in the US and internationally. Co-location with Immunology therapeutic area R&D and GCSO teams in Horsham or Springhouse, PA is required.
Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-Pennsylvania-Spring House
Organization: Janssen Global Services, LLC (6085)
Job Function: Medical Affairs
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
Global Medical Affairs Leader, Immunology-0451140128
Description
Janssen Global Services, L.L.C. (JGS) is a legal corporate entity encompassing a unique group of departments/organizations/teams that provide leadership across business critical areas for Janssen, the pharmaceutical companies of Johnson & Johnson. The following groups make up JGS: Global Commercial Strategy Organization, Global Pharmaceutical Communication and Public Affairs; U.S. Pharmaceutical Procurement Group (USPPG); and Pharmaceuticals Group Business Development (PGBD).
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Global Medical Affairs Leader (GMAL), Immunology is responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology TA. He/she will lead the Global Medical Affairs Team and partner closely with Regional Medical TA/product leaders to develop integrated global medical affairs perspectives, strategies and plans. The GMAL will be a member of the Compound Development Teams, the Safety Management Teams and Global Commercial Teams as well as an ad hoc member of the Clinical Team and Global Market Access Team and will be responsible for development of the global medical affairs plan that reflects prioritized regional needs and which are included in the overall Compound Development Plan. In addition, the GMAL will be accountable for the global publications plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for products starting in early development (phase IIA) and through launch of major life cycle management initiatives (earlier or later as needed). The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally. The GMAL, Immunology will represent global medical affairs on the Rheumatoid arthritis Disease Area Stronghold team.
The GMAL will develop global medical affairs strategy and plan for the assigned compounds based on prioritized regional needs, working with the CDT ensures integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing medical affairs global and regional value needs. This individual will provide a single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV. The GMAL is responsible for pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, and coordination of regional activity in these areas. The GMAL will be an active member of the CDT and will lead a global Medical Affairs TA Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one “unified” voice on the CDT. The role will collaborate closely with the regional medical affairs representatives to develop integrated global medical affairs strategies and plans and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions. This individual will be responsible to synchronize input and output of the Med Affairs plan with the strategic and business plan calendars. The GMAL is responsible for the development and execution of the global publication plan as well as review and approval of publications for marketed products and specified compounds in clinical development. The GMAL will manage the ReCAP process (review of all medical affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products. This individual will be responsible to support development of the Company risk management strategy and plan as well as author and review specific sections of the Periodic benefit-risk assessment report for compounds. Perform Medical impact assessments as required. The GMAL is responsible to ensure all global activities follow J&J Compliance principles, eg. Health Care Compliance , etc.
Qualifications
A minimum of a Ph.D or MD degree is required with specialty training and certification in rheumatology or gastroenterology preferred. Extensive clinical and/or pharmaceutical experience in Immunology is required. Experience in rheumatology disease area and an established network with medical experts/opinion leaders in rheumatology and/or gastroenterology is highly preferred. A minimum of 10 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required, with at least five years in the Medical Affairs environment highly desirable. Knowledge of products, both J&J and competitors, in the Therapeutic Area is preferred. A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required. A demonstrated track record of success within Medical Affairs and/or clinical R&D is needed. A global mindset and direct experience in multiple markets, proven ability to partner cross culturally/regionally required. In-depth knowledge of study methodology, study data reviews and analysis is preferred. Excellent knowledge of study execution, benefit risk management and regulatory affairs is preferred. This individual should be highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues within the TA. Proven ability to act as a medical spokesperson for external audiences is required. Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders. Proven track record on ethics and Credo type principles is needed. This role will require 35% travel in the US and internationally. Co-location with Immunology therapeutic area R&D and GCSO teams in Horsham or Springhouse, PA is required.
Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-Pennsylvania-Spring House
Organization: Janssen Global Services, LLC (6085)
Job Function: Medical Affairs
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