Jobs for People with MS: National MS Society

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview The Senior Director of the Medical Review Committee will lead and oversee the review and approval process for all Medical Materials intended to be shared externally or used to guide communications with external audiences. This role involves leading, managing and facilitating the Medical Review Committee (MRC), ensuring compliance with company policies and regulatory standards, proactively resolving issues as they arise, and maintaining the quality and accuracy of externally facing medical communications materials. As the Global MRC Chair, the Senior Director establishes and maintains a best-in-class review framework, drives global process harmonization, and collaborates with stakeholders to optimize efficiency, compliance, and strategic alignment. This individual will also provide oversight and liaise with Quality, Compliance, Legal, and Regulatory Affairs to ensure that medical review operations are audit-ready and aligned with evolving regulatory guidance. Additionally, the role includes budgetary oversight and vendor management, ensuring efficient resource allocation and high-quality service delivery. A strong candidate should demonstrate a strategic attitude, operational skills, and leadership history to promote continuous process innovation. Responsibilities 1. Global Medical Review Leadership & Strategy * Serve as Global Chair of the Medical Review Committee (MRC), overseeing medical review and approval of materials across regions to ensure accuracy, compliance, and alignment with corporate strategy. * Develop and implement a long-term strategic vision for the MRC, aligning with industry standards, business needs, and emerging regulatory trends. * Accountable for keeping the global MRC SOP and work instructions current and ensuring alignment with standard methodologies and evolving regulatory mentorship (e.g., FDA OPDP, EMA, ICH, PhRMA). * Ensure harmonization and alignment of global, regional, and local MRC policies, standard operating procedures (SOPs), and work instructions, ensuring consistency while addressing country-specific regulatory requirements. * Provide guidance on complex medical and scientific content to ensure accuracy and appropriateness for the intended audience 2. Governance, Compliance & Risk Management * Maintain a governance framework that ensures all medical materials meet regulatory, legal, and ethical standards (e.g., FDA OPDP, EMA, ICH, PhRMA). * Serve as the primary MRC liaison with Quality and Compliance teams, ensuring audit and inspection readiness by maintaining complete documentation, training records, and review histories. * Monitor and assess regulatory trends affecting MRC operations, proactively updating policies and procedures to mitigate risks and ensure compliance with global standards. 3. Operational Excellence & Performance Optimization * Oversee the end-to-end medical review process, ensuring timely and efficient review of materials while maintaining high standards of scientific and medical integrity. * EstaTo view the full job description, click hereApply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjU1MzIxLjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t