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Associate Director/Director, Regulatory Affairs Advertising and Promotion

Company: Agios Pharmaceuticals
Location: Cambridge
Posted on: June 10, 2021

Job Description:

Associate Director/Director, Regulatory Affairs Advertising and Promotion Agios (agios.com) is a biopharmaceutical company focused on providing medicines for some of the world's most challenging diseases. We're committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform. We are leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communities. We continue to foster a productive research engine that yields new insights and potential therapeutic approaches. We're a company that cares about our work, each other, and the people who are counting on us the most. We're inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results. We're driven to be our best selves, together, so we can reach for the Other Side of Possible. Agios Pharmaceuticals is searching for a dynamic Associate Director/Director of Regulatory Affairs, Advertising and Promotion to join our growing Regulatory team. The Associate Director/Director of Regulatory Affairs, Advertising and Promotion will review promotional, educational and scientific communications for Agios products to ensure scientific and medical accuracy and compliance with applicable laws and regulations. The person in this position will be the point of contact for promotional communications with the regulatory authority and facilitate the preparation of new and revised product labeling. Key Responsibilities Provides regulatory expertise in the development, review and approval of compliant, external communications directed to healthcare professionals, consumers or patients and background and training materials developed for internal use Collaborates with all stakeholders to create, review, and modify labeling documents, including prescribing information and patient labeling, with attention to competitive positioning Defines regulatory expectations for teams, identifies elements of global promotional requirements, recommends strategy for negotiations and coordinates responses to the regulatory authority Serves as the expert for the regulatory history of Agios labeling and promotional communications and for the analysis of competitor labeling in the relevant therapeutic areas Minimum Requirements Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Must have minimum of 7 years pharmaceutical industry with 3 years of promotional material and labeling review experience and interaction with FDA's Office of Prescription Drug Promotion Demonstrated knowledge of FDA, EMA and ICH guidelines and regulations, with specific expertise in advertising and promotion guidance and enforcement trends Excellent organizational and communication skills, both written and verbal Ability to work independently as well as part of a team environment Positive attitude, energetic and proactive Proven ability to manage multiple projects, identify and resolve regulatory issues Strong interpersonal skills and the ability to effectively work with others Agios Competencies Drives and Delivers : Executes and Operates to a High Standard Connect and Relate : Collaborates and Talks Straight Build and Transform : Supports a Learning Environment and Builds Networks Lead from Every Chairs : Challenges Self and Others and Drives Clarity

Keywords: Agios Pharmaceuticals, Cambridge , Associate Director/Director, Regulatory Affairs Advertising and Promotion, Other , Cambridge, Massachusetts

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