March 27, 2023 5:14 am CDT

Director, Global Labeling

  • Freelance
  • Anywhere

Takeda Pharmaceutical

nn 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. nn nn nn nn n Job Description n nn nnAt 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.nn nn nn nn OBJECTIVES: nn nResponsible for operational oversight and leadership for Takeda Global Labeling (GL), including labeling vendors assigned to GL responsibilities and tasks.n nDevelops, implements, and oversees appropriate systems to ensure compliance with external regulatory labeling requirements and internal Takeda standards.n nIs a leader both internally and externally, contributing to cross-functional initiatives and influencing the field as applicable.n nProvides leadership and development for direct reports, including those that serve as global labeling leads responsible for the design and execution of global labeling strategies in collaboration with their regional counterparts.n nn                                   nn nn ACCOUNTABILITIES: nn nPlans and manages CCDS (creation, maintenance, distribution, tracking and implementation), US, and EU labeling processes in line with strategic priorities and compliance with government regulations/Takeda quality standards to ensure commercial product integrityn nEstablishes and manages relationships with labeling vendors to ensure the effective implementation of labeling processes to meet business needs and regulatory requirements.n nMonitors Local Operating Company (LOC) compliance with labeling activities, takes corrective actions as neededn nManages preparation of the Pharmacovigilance Site Master File (PSMF) labeling sections, and inspection/audit activitiesn nParticipates with influence in or leads departmental and cross-functional task-forces and initiatives n nIdentifies risks with mitigation plans and communicates with Therapeutic Area Team Leadn nServes as a labeling resource to the Therapeutic Area Units, Marketed Products, and US/EU Labeling Operations as well as Local Operating Companies for labeling issuesn nLeads the development of new strategic and operational initiatives to improve the efficiency of Global Labeling, US and EU labeling operationsn nMonitors industry labeling trends and proposes actions as appropriaten nProvides leadership to GL staff (including Takeda employees, vendors, and partners) in establishing roles/responsibilities and accountabilities across the labeling function(s).n nn nn nn SCOPE OF SUPERVISION: nn nn NUMBER SUPERVISED WORKERS nn nn Direct 0-8nn nn In-Direct 0-10nn nn nn nn EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: nn nBSc Degree, preferred.  BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferredn n10+ years of pharmaceutical industry experience.  This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience. n nUnderstanding of scientific principles and regulatory/quality systems relevant to drug development. n nKnowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred). n nStrong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.n nDemonstrates problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions. n nMust work well with others and within global teams. n nAcceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identifies issues; offers creative solutions and strategies, including risk mitigation strategies.n nResponsible for demonstrating Takeda leadership behaviors.n nn nn nn LICENSES/CERTIFICATIONS: nn nNone required.n nn nn nn PHYSICAL DEMANDS: nn nManual dexterity required to operate office equipment (i.e. computers, phones, etc.).n nCarrying, handling and reaching for objects.n nAbility to sit or stand for long periods of time while traveling.n nn nn nn TRAVEL REQUIREMENTS: nn nWillingness to travel to various meetings, including overnight trips.n nRequires approximately up to 10-30% travel.n nn nn nn Base Salary Range: $156,000 to $224,000, based on candidate 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. This posting is made in compliance with Colorado’s Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq nn nn nn nn nn nn EEO Statement nn nn 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, and any other characteristic protected by law. nn nn n Locations n nnMassachusetts – Virtual nn nn nn n Worker Type n nnEmployee nn n Worker Sub-Type n nnRegularnn nn n Time Type n nn nnFull time nn #LI-Remotenn




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