Takeda
2 days ago Be among the first 25 applicants
This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $153,600.00/yr - $241,340.00/yr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
About the role At Takeda, we are a forward‑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 Takeda as Associate Director, Global Labeling Lead where you will be 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.
How you will contribute
With guidance from leadership: Management of Labeling Cross‑Functional Teams.
Independently lead Labeling cross‑functional teams driving collaboration and alignment of the labeling strategy and content.
Interface with Senior Management Cross‑Functional Team (GLOC): Coordinate the process to obtain labeling approval by Labeling Senior Management Cross‑functional team (Global Labeling Oversight Committee – GLOC) and ensure preparation and alignment of GLOC Chair(s) and GLOC members.
Labeling Documents Authoring, Submission, and Labeling Negotiations: Author new/revised TLP, CCDS, USPI and/or EU SmPC; develop and execute a labeling implementation plan to incorporate new data; manage outgoing communications regarding significant labeling changes; coordinate global labeling sub‑functions for timely submissions.
Manage Local Exceptions and LOC Interactions: Align local labeling with CCDS, assess exceptions and deferrals, and support local affiliates with health authority requests.
Escalation Process and Stakeholder Management: Escalate issues to Global Labeling management and GRL, propose risk mitigation, cultivate relationships with cross‑functional teams, and ensure communication effectiveness.
Precedent Search and Labeling Trends: Conduct precedent analysis and develop labeling strategies and language; represent global labeling at regulatory teams; liaise with label operations and compliance.
Vendor Management: Oversee labeling activities managed by external vendors, ensuring coordination, delivery, and quality standards.
Continuous Improvement: Identify opportunities to optimize labeling processes and implement strategies to enhance efficiency.
Minimum Requirements / Qualifications
BSc degree, preferred; BA accepted.
Advanced scientific degree (MSc, PhD, or PharmD), preferred.
8+ years of pharmaceutical industry experience, including 6 years of labeling experience or 5+ years of regulatory and/or related experience.
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 update product labeling with minimal supervision.
Ability to develop target labeling profile (TLP) with minimal supervision.
Understanding of global labeling concepts and implications across the organization.
Knowledge of health authority audit processes and ability to participate in audits and inspections.
Additional Information At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
This position is currently classified as “remote” following Takeda’s Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
Location & Salary Massachusetts – Virtual. U.S. Base Salary Range: $153,600.00 – $241,340.00.
The actual base salary offered may depend on qualifications, experience, skills, education, certifications, and location. U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, 401(k) plan, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, sick time, and paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, 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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Business Development and Sales
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr
This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $153,600.00/yr - $241,340.00/yr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
About the role At Takeda, we are a forward‑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 Takeda as Associate Director, Global Labeling Lead where you will be 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.
How you will contribute
With guidance from leadership: Management of Labeling Cross‑Functional Teams.
Independently lead Labeling cross‑functional teams driving collaboration and alignment of the labeling strategy and content.
Interface with Senior Management Cross‑Functional Team (GLOC): Coordinate the process to obtain labeling approval by Labeling Senior Management Cross‑functional team (Global Labeling Oversight Committee – GLOC) and ensure preparation and alignment of GLOC Chair(s) and GLOC members.
Labeling Documents Authoring, Submission, and Labeling Negotiations: Author new/revised TLP, CCDS, USPI and/or EU SmPC; develop and execute a labeling implementation plan to incorporate new data; manage outgoing communications regarding significant labeling changes; coordinate global labeling sub‑functions for timely submissions.
Manage Local Exceptions and LOC Interactions: Align local labeling with CCDS, assess exceptions and deferrals, and support local affiliates with health authority requests.
Escalation Process and Stakeholder Management: Escalate issues to Global Labeling management and GRL, propose risk mitigation, cultivate relationships with cross‑functional teams, and ensure communication effectiveness.
Precedent Search and Labeling Trends: Conduct precedent analysis and develop labeling strategies and language; represent global labeling at regulatory teams; liaise with label operations and compliance.
Vendor Management: Oversee labeling activities managed by external vendors, ensuring coordination, delivery, and quality standards.
Continuous Improvement: Identify opportunities to optimize labeling processes and implement strategies to enhance efficiency.
Minimum Requirements / Qualifications
BSc degree, preferred; BA accepted.
Advanced scientific degree (MSc, PhD, or PharmD), preferred.
8+ years of pharmaceutical industry experience, including 6 years of labeling experience or 5+ years of regulatory and/or related experience.
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 update product labeling with minimal supervision.
Ability to develop target labeling profile (TLP) with minimal supervision.
Understanding of global labeling concepts and implications across the organization.
Knowledge of health authority audit processes and ability to participate in audits and inspections.
Additional Information At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
This position is currently classified as “remote” following Takeda’s Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
Location & Salary Massachusetts – Virtual. U.S. Base Salary Range: $153,600.00 – $241,340.00.
The actual base salary offered may depend on qualifications, experience, skills, education, certifications, and location. U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, 401(k) plan, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, sick time, and paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, 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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Business Development and Sales
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr