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location: Telecommute
job type: Contract
salary: $130.00 - 142.97 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance.
With guidance from leadership:
Management of Labeling Cross-Functional Teams
- Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC)
- In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels.
- Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.
- Authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance.
- With adequate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well 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.
- Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance.
- Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL).
- Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements.
- Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance.
- Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc
- Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation.
- Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content.
- Conducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals.
- Represents Global Labeling at Global Regulatory Team (GRT)
- Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.
- Represents global labeling in departmental and cross-functional task-forces and initiatives.
- Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.
- Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.
- Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.
qualifications:
- BSc degree, preferred; BA accepted.
- Advanced scientific degree (MSc, PhD, or PharmD) preferred.
- 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
- Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management.
- Demonstrates an understanding of core business aspect.
- Ability to effectively collaborate with global cross-functional teams.
- Ability to use communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation formats.
- Ability to promote regulatory decisions across global cross-functional teams.
- Ability to actively listen to stakeholders, understanding their perspectives and addressing their concerns.
- Demonstrates strong analytical and problem-solving skills with ability to analyze risk and think strategically.
- Ability to comprehend and explain complex technical regulatory issues.
- Ability to assess labeling related regulatory requirements, identify issues or opportunities, escalate to leadership, as needed, and make informed decisions.
- Ability to proactively identify risks, develop risk mitigation strategies, and appropriately escalate to leadership.
- Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).
- Knowledge of US and/or EU regulatory requirements and guidelines.
- Knowledge of other relevant regional regulatory nuances and requirements.
- Knowledge of scientific principles and regulatory/quality systems relevant to drug development.
- Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance.
- Ability to develop target labeling profile (TLP) with minimal supervision and guidance.
- Understanding of the broad concepts within global labeling and implications across the organization and globally.
- Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections.
- Strong knowledge of labeling role in project teams, and importance of cross-functional collaboration.
- Knowledge of R&D organizational structure, including its functions and interdependencies.
- Demonstrates project management skills and ability to independently deliver accurate and complete work while adhering to designated timelines for the execution of submission plans, regulatory requirements and business objectives.
- Demonstrates a strategic mindset and ability to align product labeling strategies with broader business objectives.
- Ability to independently prioritize assigned global labeling activities and tasks.
- Acts proactively and effectively as member of multi-disciplinary teams.
- Ability to effectively lead multi-disciplinary, cross-functional teams with appropriate supervision and guidance.
- Ability to provide alternatives and to adopt breakthrough ideas, innovations and initiatives.
- Acts as an ally to support individuals as a whole and intentionally promotes an inclusive culture and fosters a climate that encourages open dialogue, feedback and diverse opinions.
- Demonstrates company values: Integrity, fairness, honesty, and perseverance.
- Ethical decision making: considers the impact of decisions and actions on others, adhering to professional codes of conduct and making choices that align with Takeda values.
- Timeline management: ability to effectively manage time, prioritize tasks, and meet deadlines.
- Proactiveness, adaptability and flexibility: ability to adapt to changing circumstances, learn new skills and work with diverse global team by being open to feedback.
- Attention to details
skills: Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
