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Regulatory Labeling Strategy Lead, Associate Director

応募後で応募 求人ID R0034500 掲載日 06/15/2021 Location:Boston, Massachusetts; Vienna, Austria

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as an Associate Director Labeling Strategy Lead in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director Labeling Strategy Lead, you will be empowered to ensure global strategies are successfully executed across both new product development and existing portfolio life cycle management, and a typical day will include: 

Primary Duties

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases.  There are two main drivers of innovation that are the focus of the PDT R&D organization:

  • Translational Pharmaceutical Sciences - a rapid-cycle innovation engine to develop improvements to existing products, develop new products, and improve yield.  It combines translational research with pharmaceutical/manufacturing sciences, device development and clinical research.
  • Precision Medicine - a patient-centric research focus with the goal to develop comprehensive, value-oriented health care delivery packages around drug products targeted to maximize benefit and reduce risk to precise patient populations.  In the process, this engine will drive innovation by practicing patient-centric R&D.

With minimal supervision, the Regulatory Labeling Strategy Lead, PDT BU is responsible for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within PDT BU’s Global Labeling function (Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP) for PDT BU products).  Ensures that there is strategic labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.  Formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information. Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance.

Key Skills, Abilities, and Competencies

  • Proven leader.  Recognized as a leader both internally and externally.  Demonstrates leadership skills and the ability to effectively motivate, mentor and manage direct reports and diverse team members.  Inspires colleagues and is sought after for contribution to cross-functional initiatives.  Interacts with external stakeholders and is influential to the Global Labeling external community as applicable. 
  • Drives organizational change.  Identifies and implements continuous improvement strategies.   
  • Self-starter.  Demonstrates initiative in advancing strategic projects with minimal guidance.
  • Potential and desire for future growth.  Has a strategic mindset and executive presence.  Ability to serve as backup to the Head of Labeling on occasion.
  • Extensive knowledge of global regulatory and compliance requirements and demonstrated ability to function as the interface with global Regulatory Authorities.
  • Ability to use precedent and previous experience to develop innovative and flexible approaches to ensure regulatory compliance.
  • Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.   Projects confidence and poise when facing a challenging environment.   Through effective communication and collaboration, can resolve issues and garner alignment.
  • Ability to negotiate and influence without authority in a matrix environment.
  • Crisp decision-making following appropriate consultation, even in times of ambiguity.
  • Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU and international markets.
  • Must be able to work in a fast paced, highly matrixed, GPT-oriented work environment with demonstrated ability to prioritize and complete multiple competing tasks and demands.
  • Excellent interpersonal, written and oral communication, analytical, managerial, and organizational skills.
  • Proficient in business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat, Outlook, and Sharepoint.  Experience utilizing other business systems, including electronic document management systems and tracking systems.

Education and Experience Requirements

  • Bachelor's degree in a scientific discipline or closely related field is required.  Advanced degree, such as Pharm D, PhD, MD or JD preferred.
  • Minimum of 7-10 years of experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.).  5-7 years of direct experience in a global, US, or EU labeling role is desired.
  • Previous leadership experience and management of direct reports preferred.
  • Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling, specifically, EU and US labeling requirements and guidance.  Combination product/drug-device labeling knowledge is preferred.  Advertising and promotion knowledge is a plus.
  • Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.
  • Understanding of SPL format, requirements and guidance for legacy and PLR labels.
  • Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labeling Tracking Systems to support labeling documentation, tracking, and compliance activities.

Other Job Requirements

~15-20% national and international travel anticipated

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please

This job posting excludes CO applicants

Locations

Boston, MA

AUT - Vienna - Kärntner Ring

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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