Job Detail

Ass. Dir. Global Labelling Lead

Inseriert am: 25.11.2020

Ass. Dir. Global Labelling Lead


Boston, Massachusetts, Zurich, Switzerland

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  • Overview

  • Success

  • Life at Takeda

  • Opportunity

  • Responsibilities

  • Map


Overview


Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.


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Success


What makes a successful member of our team?


We take action and make decisions by focusing on our four priorities in this order:



  • 1

    Putting the patient
    at the center


  • 2

    Building trust
    with society


  • 3

    Reinforcing our
    reputation


  • 4

    Developing the
    business



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Life at Takeda



  • Our people

    To keep delivering new value to patients, we provide growth opportunities for every employee according to their abilities and passions, and together are building a stronger organization.


  • Anders Tellefsen

    Procurement Lead, Northern Europe

    “Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”

  • Yves Leurquin

    Regional Head, Europe, Vaccines

    “Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”


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Opportunity



  • Inclusive

    Here, you will feel welcomed, respected, and valued as a vital contributor our global team.


  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.


  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.


  • Values-Led

    Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.


  • People-First

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.


  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.



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Ass. Dir. Global Labelling Lead

Apply NowJob ID R0024799Date posted 11.25.2020Location Boston, Massachusetts; Zurich, Switzerland

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.


Job Description


The Global Labelling Lead (GLL) has the overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of the Company Core Data Sheet (CCDS) and all centrally managed labels within VBU (e.g. USPI, EUSmPC, WHO leaflet and associated labelling documents)



The GLL will guide and advise the Labelling Working Group (LWG) on internal labeling guidances and policies and will raise awareness of important factors to consider when revising the label. He/she will keep up to date with all relevant labeling guidelines, SOPs, and regulations and will advise the LWG on the application of these labeling principles. He/she will also be knowledgeable on key labeling requirements worldwide, in order to ensure that CCDS/CSI updates may be implemented globally. He/she will review the downstream impact of CCDS/CSI updates on Local Product Documents (LPD) and ensure that downstream impact on LPDs is considered during LWG discussions. The GLL will advise the LWG on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text.


Provides project management to the LWG throughout the entire process, from the decision to update a CCDS/CSI/USPI/SmPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets and prioritization plans, ensuring that LWGs are aware of the required timelines and following up with LWG members throughout the process so that deliverables remain on target to meet internal and external deadlines.


Will support the use and development of current and new tools, technologies, SOPs,  and processes to support efficient global label development and worldwide submissions and approvals.


Locations


Zurich, Switzerland


Boston, MA


Worker Type


Employee


Worker Sub-Type


Regular


Time Type


Full time

Job ID R0024799

Apply NowEmail Me

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Ass. Dir. Global Labelling Lead

Apply NowJob ID R0024799Date posted 11.25.2020Location Boston, Massachusetts; Zurich, Switzerland

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.


Job Description


The Global Labelling Lead (GLL) has the overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of the Company Core Data Sheet (CCDS) and all centrally managed labels within VBU (e.g. USPI, EUSmPC, WHO leaflet and associated labelling documents)



The GLL will guide and advise the Labelling Working Group (LWG) on internal labeling guidances and policies and will raise awareness of important factors to consider when revising the label. He/she will keep up to date with all relevant labeling guidelines, SOPs, and regulations and will advise the LWG on the application of these labeling principles. He/she will also be knowledgeable on key labeling requirements worldwide, in order to ensure that CCDS/CSI updates may be implemented globally. He/she will review the downstream impact of CCDS/CSI updates on Local Product Documents (LPD) and ensure that downstream impact on LPDs is considered during LWG discussions. The GLL will advise the LWG on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text.


Provides project management to the LWG throughout the entire process, from the decision to update a CCDS/CSI/USPI/SmPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets and prioritization plans, ensuring that LWGs are aware of the required timelines and following up with LWG members throughout the process so that deliverables remain on target to meet internal and external deadlines.


Will support the use and development of current and new tools, technologies, SOPs,  and processes to support efficient global label development and worldwide submissions and approvals.


Locations


Zurich, Switzerland


Boston, MA


Worker Type


Employee


Worker Sub-Type


Regular


Time Type


Full time

Job ID R0024799

Apply NowEmail Me

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Details