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The GMAL - Gastroenterology (GI), under direction of the Head Global Immunology Medical Affairs - Gastroenterology, is responsible for leading certain aspects of the clinical-commercial optimization for asset development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology- Gastroenterology TA. S/he will partner closely with the GMA Operations Leader, Regional Medical TA/product leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans. He/she will be a member of the Global Medical Affairs Team (GMAT) and partners closely with Regional Medical TA/product leaders to develop to support the Head Global Immunology Medical Affairs - Gastroenterology in the building global medical affairs perspectives, strategies. The GMAL GI acts as a member of the Safety Management Team, Global Commercial Team as well as an ad hoc member of the Clinical Team and Global Market Access Team. The GMAL GI will be responsible for development of the Global Medical Affairs (GMA) plan that reflects prioritized regional needs and which are included in the overall Compound Development Plan. In addition, the GMAL GI will be accountable for the global publication plans, global opinion leader relationships, and global advisory boards. The GMAL has primary medical responsibility in responding to requests and representing clinical aspects to external stakeholders including governments, health authorities, KOLs, NGOs, and supra-governmental organizations, such as WHO, CDC etc.

• Development of GMA strategy and plan for the assigned compounds (whether in development or marketed) based on prioritized regional needs in alignment with defined global medical objectives
• Collaborate closely with the regional medical affairs and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions
• Responsible for internal training strategy to assure continuous education of global and regional market access and medical affairs teams
• Responsible for global publications planning process oversight (pre-launch and throughout lifecycle) including manuscripts, abstracts, posters and papers as well as pre-launch global KOL communications & speaker development
• Review of manuscripts to ensure alignment with strategy and effective communication/presentation in internal and external audiences
• Responsible for pre- and post-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas
• Responsible for medical education strategy as well as creation and approval of medical material for external use (e.g. HCP education)
• Responsible for opinion leader relations product/Therapeutic Area global advisory boards
• Responsible to provide medical input into market research and health outcomes research conducted by commercial and market access teams, respectively
• Responsible to support commercial teams in the creation of promotional material
• Will lead/participate to create one Medical Affairs perspective and one "unified" voice on the CDT
• Responsible for the Management of the ReCAP process (review of all Medical Affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products
• Supporting development of the company risk management strategy and plan as well as author and review specific sections of the Periodic Benefit-Risk Evaluation Report for compounds. Performance of Medical Impact assessments as required
• Responsible to ensure all global activities follow J&J compliance principles, (e.g. Health Care Compliance, etc.)

Qualifications

• MD/DO or PhD degree (or equivalent) with training and certification in Gastroenterology is highly preferred. Other advanced scientific degree e.g. PharmD may be given consideration
• A minimum of 5-8 years of combined experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required, with at least three years in the Medical Affairs environment is highly desirable
• Clinical and/or pharmaceutical experience in immunology required and gastroenterology is highly preferred
• A demonstrated track record of success within Medical Affairs and/or clinical R&D is highly preferred
• Having an established network with medical experts/opinion leaders in IBD/GI is highly preferred
• Strategy development expertise is highly preferred
• Ability to work in a matrix environment and understands global complexity is required
• Global mindset and ability to partner cross culturally/regionally is required
• Proven ability to act as a medical spokesperson for external audiences is required with superior communication skills oral and written is required
• Excellent knowledge of study/clinical methods, study execution, data analysis & review, benefit risk management and regulatory affairs is highly preferred
• Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues is required
• Proven track record of ethical decision making is required
• Experience in patient advocacy and engagement is highly desirable
• Approximately 30% US & international travel is required
• This position is located in Horsham, PA and follows a hybrid schedule of three days in the office and two days remotely per week.

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.

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