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Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies.
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As Intercept continues to build its position as the leader in rare and serious liver disease, we are seeking a Director, Access Marketing. The role reports to the SVP, Strategic Marketing, with a dotted line to the Vice President of Market Access.
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Clinical sales background with experience in rare disease, Neurology/Neuromuscular Specialist, managing large/multi-state geography, and being accountable for own business strongly preferred.
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Develop a national sales/business plan based on analysis and deep understanding of product strategy, market access landscape in key geographies, patient journey and other marketplace issues/opportunities to exceed launch sales goals.
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Lead the UPLIZNA IgG4-RD cross-functional launch team, collaborating closely with cross-functional partners including Medical Affairs, Global, Marketing, Market Research, Market Access, Consumer Marketing, Commercial Development, Clinical Development, Regulatory Affairs, Sales, Patient Services, Patient Advocacy, Training, Trade, etc.
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Collaborate with multiple teams (Marketing, Patient Services, Alternate Site Team, Integrated Health Systems, Market Access, and National Accounts) to ensure high levels of customer satisfaction and pull through of opportunities within each geography.
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7+ years of sales experience, a portion of which must include two or more of the following areas: infusion, diagnostic, biologic, medical device, buy and bill, rare disease, specialty pharmacy, and/or neurology.
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Experience in infectious disease, rare disease, oncology, and women's health. Collaborate and align efforts with internal Astellas stakeholders to engage with key healthcare systems including compliant partnership with other sales teams, medical, and market access teams.
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As a pivotal leader in the Market Access & Pricing and HEOR team, the Sr. Director, MA&P, for Rare Diseases will drive the strategic development and hands-on execution of access, reimbursement, and commercialization efforts for Moderna's innovative Rare Disease portfolio.
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KMK has five business arms spanning Commercial Operations and Analytics, HEOR/RWE, Strategy, Market Access and Market Research. Hemtology-Oncology or rare disease experience a plus.
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2+ years recent Specialty and or Rare Disease experience preferred. Understand and apply knowledge of health care industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy-economics, payer/ reimbursement landscape and patient flow/influence.
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My client is looking to bring on a Sr. Director/VP of Market Access to craft the approach for cutting-edge rare disease treatments, ensuring their delivery to those in need.
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Contributes US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications. This position can be located in Cambridge, MA or Bridgewater, NJ. Hybrid remote working arrangement can also be considered.
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