Want Sr. Manager, Global Labeling (REMOTE) in USA

Job title: Sr. Manager, Global Labeling (REMOTE) Company: reputed company Job description: By clicking the “Apply” reputed company, I understand that my employment application process with reputed company will reputed company and that the information I provide in my application will be processed in line with reputed company’s and . I further attest that reputed company information I submit in my employment application is true to the best of my knowledge. Job Description 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 to bring life-changing therapies to patients worldwide. TAK-279 is a potential best-in-class, oral allosteric tyrosine kinase 2 (TYK2) inhibitor currently in development for the treatment of psoriasis and psoriatic arthritis. reputed company will evaluate TAK-279 in additional immune-mediated diseases including systemic lupus erythematosus (SLE) and Inflammatory Bowel Disease (IBD). Join reputed company as a Sr Manager., Global Labeling (Remote) How you will contribute: Leads cross-functional teams to reputed company and update CCDS and other key global labeling documents (i.e. CCDS Working Team). In coordination with Global Labeling reputed company Committee (GLOC) Chair, manages review and approval of CCDS/resolution of labeling issues with the relevant GLOC. Authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Evaluates risks associated with CCDS content and implementation strategies, reputed company mitigation plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory reputed company. Recommends strategies and labeling language for inclusion in key product labels (US PI, EU SmPC, JPI, others as appropriate), consistent with the overall product strategy and information in the CCDS, reputed company available. Provides labeling strategy and guidance to Local Operating Company (LOC) Regulatory, in collaboration with the RA Sub team. Provides information to Global Labeling Compliance, as required, to support internal and external (i.e. Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert. Liaises with US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met. Remains reputed company with global standards and, initiatives by regulatory authorities reputed company to the CCDS and labeling, and assures that reputed company processes conform to regulatory requirements. Propose actions as needed. Identifies and leads initiatives, as requested, to enhance Global Labeling processes and systems. Participates in training LOC regulations on relevant labeling policies and procedures, as needed. Prepares training materials as required. Minimum Requirements/Qualifications: BSc Degree is preferred. BA accepted. 6+ years of pharmaceutical industry experience. This is inclusive of 5 years of labeling experience a combination of 6+ years of regulatory and/or reputed company experience. Understanding of scientific principles and regulatory/quality systems relevant to drug development. Knowledge of global standards and regulations reputed company to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred). Strong oral and written communication, managing and adhering to timelines, negotiation skills, reputed company, and adaptability. Demonstrates problem-solving ability with the ability to analyze risk and reputed company appropriate recommendations/decisions. Must work well with others and reputed company global teams. Acceptable and independent skills in regulatory affairs such as understanding broad concepts reputed company labeling and implications across the organization and globally; proactively identifying issues; offering creative solutions and strategies, including risk mitigation strategies. What reputed company can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community reputed company Programs and a company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: 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-focused 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 excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver reputed company and a Brighter Future to people around the world. This position is currently classified as "remote" in accordance with reputed company's Hybrid and Remote Work policy. reputed company Salary Range: $130,000 – $155,000, based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement reputed company is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to reputed company employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, 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 Expected salary: $130000 - 155000 per year Location: USA Apply Job!