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Medical Writing Lead - Vaccines

Zurich, Switzerland


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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  • Anders Tellefsen

    Procurement Lead, Northern Europe

    Anders Tellefsen
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  • Yves Leurquin

    Regional Head, Europe, Vaccines

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

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Medical Writing Lead - Vaccines

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Job ID R0014879 Date posted 12/02/2019 Location Zurich, Switzerland

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Job Description

Medical Writing Lead - Vaccines

  • Provide leadership and expertise necessary to develop and execute the overall strategy of the Clinical Development  medical writing function
  • Reliably and efficiently deliver clinical documents to support global clinical program and regulatory submission requirements
  • Drive standardization while providing critical expertise to support functional and global clinical vaccine program requirements
  • Establish global operating and quality standards and ensure ongoing performance against these standards

  • Provide strategic direction and leadership to the global medical writing function including external headcount and CROs
  • Targeted alignment with VBU Japan for document standards and global program and submission document requirements
  • Serve as global decision-maker for the medical writing function including representative in interactions with functions within VBU clinical development  (e.g., clinical teams, regulatory affairs, development delivery, discovery ), outside Clinical Development (e.g., global  medical affairs) and external vendors
  • Ensure reliable execution and delivery (quality, cost and time) of clinical documents to support global program and submission requirements

  • Set performance standards
  • Oversight of document authoring and publishing plans and execution
  • Ongoing monitoring of issues/risks and remediation measures
  • Ownership of all Clinical Development document standards such as protocols and clinical study reports
  • Lead global clinical trial disclosure activities to ensure compliance with all regulatory and Takeda requirements associated with clinical trial posting and results disclosure
  • Develop and implement an efficient operating model for the global medical writing function including outsourcing strategy, operating processes, enabling technologies, staffing model, roles and responsibilities
  • Efficiently leverage external vendor resources while retaining sponsor oversight for performance and quality
  • Ensure compliance with all applicable internal policies and procedures, GCPs, and all applicable regulations; ensure inspection readiness of all regulated activities
  • Contribute to creating a culture and values that attracts, retains, and develops the most effective people


  • Minimum BS degree in life science, English or other applicable scientific degree with MS, PhD or MD preferred
  • Significant previous experience leading the medical writing activities for major global submissions
  • Scientific and medical experience/expertise sufficient to understand and be conversant on key issues in relevant therapeutic areas.
  • Experience operating in a multi-disciplinary drug development environment, including international exposure and experience in a variety of therapeutic areas
  • Experience working within a complex organization and demonstrated ability to work across functions and regions, at all levels without direct authority
  • Strong leadership capability with advanced skills in team building, motivating, and developing people
  • Proven success in effectively managing external vendors / resources
  • Advanced knowledge of ICH guidelines, and local regulatory requirements and processes as related to document content, organization, format, and production.
  • Ability to assess issues/risks and effectively implement remediation measures
  • Experience with global regulations and global regulatory inspections
  • Understanding of clinical trial information management and publishing technologies
  • Ability to comprehend and synthesize complex data, identify issues and trends and develop and implement solutions/plans
  • Strong proven ability to manage large and complex global change agendas
  • Ability to influence and work effectively with various business partnerships, regions, and cultures
  • Excellent communicator with strong written and verbal presentation skills



Zurich, Switzerland

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0014879

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