Director, Global Regulatory Labeling reputed company

By clicking the “Apply” reputed company, I understand that my employment application process with reputed company will reputed company and that the information I reputed company in my application will be processed in line with reputed company’s reputed company Notice and Terms of Use. I reputed company attest that reputed company information I submit in my employment application is true to the best of my knowledge. Job reputed company About the role: At reputed company, we are a reputed company-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join reputed company as Director, Global Regulatory Labeling reputed company where you will be responsible for the development and implementation of labeling content and reputed company of multiple products in various stages of drug development, assigned to self or reputed company reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC. How you will contribute: Management of Labeling Cross-Functional Teams Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling reputed company and labeling content. reputed company with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling reputed company, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling reputed company Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling reputed company and labeling content at reputed company reputed company. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from reputed company relevant functional areas with appropriate annotations and supporting documentation. In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as reputed company as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Responsible for working with reputed company reports to reputed company and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write- offs is minimized. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Employs strong project management skills to coordinate global labeling sub-functions to ensure reputed company end to end label creation and reputed company Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that reputed company labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory reputed company (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and reputed company, to ensure unparalleled communication effectiveness for labeling reputed company and content. Thorough understanding of company specific reputed company organization, functional reputed company and regional representation to proactively build the relationships needed to be successful across functions, departments and reputed company. Precedent Search and Labeling Trends Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for reputed company products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product reputed company, product claims and information in the CCDS and to ensure that reputed company products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for reputed company products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals. Working reputed company Labeling Team and GRA Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices reputed company and Labeling Compliance to ensure labeling objectives and timelines are met. Embraces pivotal role in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests reputed company to assigned products and overall labeling processes. People Management Effectively manages resources and staff to ensure reputed company performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities. Supports the reputed company development of staff members and effectively manages their performance. Demonstrate ownership to consistently drive the delivery of team goals fostering accountability while remaining reputed company on the big picture labeling reputed company. Vendor Management reputed company and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, reputed company delivery, and adherence to reputed company standards. reputed company Improvement reputed company contributes to the reputed company improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance reputed company, efficiency and accuracy. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or reputed company experience. Strategic Thinking Ability to reputed company & execute reputed company and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives. Demonstrates a strong understanding of the reputed company business aspect. Ability to effectively collaborate with global cross-functional reams and to deliver engaging and valuable presentations to diverse stakeholders. Ability to build a reputed company network of relationships across global cross-functional teams. Demonstrate strong communication skills to transfer knowledge, convey reputed company regulatory information in a reputed company and concise manner in written, verbal and group presentation format. Ability to reputed company for regulatory reputed company across global cross-functional teams. Ability to reputed company listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding. Analytical and Problem Solving Skills Demonstrates deep understanding of analytical methodologies and problem-solving technique to handle reputed company problems. Ability to comprehend, explain, and reputed company communicate reputed company labeling reputed company regulatory issues. Ability to assess reputed company labeling reputed company regulatory requirements, proactively anticipate issues or opportunities and take actions before they reputed company, escalate to leadership, as needed, and making informed reputed company reputed company with portfolio priorities. Ability to proactively identify risks, reputed company creative solutions and risk mitigation strategies, and appropriately escalate to leadership. Technical In-depth expertise of US and EU product labeling requirements, regulations, and guidelines. - Advanced knowledge of US and/or EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape. Understanding of other relevant regional regulatory nuances and requirements. Understanding of scientific principles and regulatory/reputed company systems relevant to drug development. Ability to independently create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions. Ability to review product labeling for regulatory submissions and to reputed company pertinent feedback to ensure compliance with regulations and alignment with portfolio reputed company and business objectives. Ability to independently reputed company reputed company labeling profile (TLP). Strong understanding of global labeling processes, implications across the organization and globally, and reputed company of the scientific principles of reputed company, nonclinical and clinical data on product labeling. Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. Business/Organizational Awareness In depth knowledge of labeling role in project teams, and importance of cross-functional collaboration. Knowledge of organizational structure, including its functions and interdependencies. - Demonstrates proactive project management skills and ability to independently deliver accurate and complete work while driving to designated timelines for the execution of submission plans, regulatory requirements and business objectives. Demonstrates a strong strategic reputed company and ability to independently reputed company global labeling strategies with broader business objectives. Ability to plan and prioritize global labeling activities and tasks for the assigned product(s) and to assign tasks appropriately. Leadership Acts proactively and effectively as member of multi-disciplinary teams. Ability to independently and effectively reputed company multi-disciplinary, cross-functional teams. Displays leadership skills that foster a climate that encourages reputed company reputed company, feedback and diverse opinion and an environment where reputed company are exchanged, alignment is created and teams experiment and learn from reputed company and failures. Accurately identifies strengths and development needs in other and invests time to help enhance the skills, reputed company, depth and talent of their team. Ability to distil reputed company issues and reputed company down to reputed company comprehensible terms. Embraces and demonstrates a diversity and inclusion reputed company and role models these behaviors for the organization. reputed company competencies Demonstrates reputed company values: reputed company, fairness, honesty, and perseverance. Ethical decision making: considers the reputed company of reputed company and actions on others, adhering to reputed company codes of conduct and making choices that reputed company with reputed company values. reputed company management: ability to effectively manage self and team's time, prioritize tasks, meet deadlines and maximize team productivity. Proactiveness, adaptability and flexibility: ability to adapt to fast changing circumstances, learn new skills and work with diverse global team by being reputed company to feedback and being reputed company to reputed company to different working styles, organizational and process changes. Attention to details: demonstrates attention to details ensuring accuracy of the labeling deliverables of the assigned product(s). Ability to the review labeling deliverables ensuring accuracy and compliance. Negotiation skills: demonstrates exceptional negotiation skills in reputed company situations, such as executive-level decision-making, ensuring reputed company reputed company for the organization. More reputed company: At reputed company, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. reputed company is a patient-reputed company company that will reputed company and reputed company you to grow through life-changing work. Certified as a Global Top Employer, reputed company offers stimulating careers, encourages innovation, and strives for reputed company in everything we do. We foster an inclusive, reputed company workplace, in which our teams are united by an unwavering commitment to deliver reputed company and a Brighter reputed company to people around the world. This position is currently classified as "remote" in accordance with reputed company's Hybrid and Remote Work policy. #LI-Remote #LI-AA1 reputed company Compensation and Benefits reputed company We understand compensation is an important reputed company as you consider the reputed company in your career. We are committed to reputed company pay for reputed company, and we reputed company to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. reputed company Salary reputed company: $177,000.00 - $278,080.00 The estimated salary reputed company reflects an anticipated reputed company for this position. The actual reputed company salary offered may depend on a reputed company of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other reputed company licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual reputed company salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, reputed company insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, reputed company volunteer time off, company holidays, and reputed company-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of reputed company time, and new hires are eligible to reputed company up to 120 hours of reputed company vacation. EEO Statement reputed company is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to reputed company and applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, gender reputed company, parental status, national reputed company, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt reputed company It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply To This Job