Director, Medical Writing, Vaccines

At our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

Join us as a Director Medical, Writing for our Vaccines Business Unit, based in Zurich. Here, you will be a vital contributor to our inspiring, bold mission.

Objectives:

The Director, Medical Writing is responsible for strategically planning and resourcing the medical writing deliverables that support Takeda’s business objectives for clinical development for Vaccines Business Unit with multiple compounds through all phases of development.

This position provides medical writing therapeutic leadership responsible for the oversight and execution of the medical writing strategy in line with global medical writing objectives as well as Clinical Program Leadership and serves as a senior strategic Medical Writing resource to clinical development teams for its vaccine development activities.

He/She is responsible for Medical Writing global submission timelines/planning/forecasting and budget management (administrative budget and for direct reports) for assigned therapeutic area.

Accountabilities:

• Provides global medical writing strategic direction and leadership for Vaccines Business Unit across multiple compounds
• Accountable for developing, implementing and assuring execution of strategic global medical writing plans.
• Accountable for overall direction of multiple, large, complex regulatory submissions.
• Provides oversight for the development, approval, and implementation of medical writing processes, standards, style guidelines and templates.
• Guides medical writing activities (including document preparation and/or production) for assigned regulatory submissions or projects.
• Formulates writing strategy for key documents, including organization, content, timelines, and resource requirements; ensures that needs (e.g. headcount, funding, time) are appropriately represented to relevant teams and management.
• Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
• As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
• Provides leadership on functional teams that address requirements or issues related to document preparation and production.
• Reviews availability of sufficiently qualified vendor resources on a regular basis, contribute to planning of future vendor resource needs; generally through departmental resource reviews, vendor assessment strategies, including vendor forecasts.
• Provides oversight external vendors for implementing and assuring execution of strategic medical writing plans. - Coordinates the activities of Takeda and contract employees (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
• Oversees compliance with relevant internal and external standards and maintains a functional group that meets or exceeds industry standards.
• Aligns project and resource priorities that with the business objectives and establishes, conveys and executes plans that drive toward goal achievement.
• Works with medical writing leadership to deploy resources and develop processes to ensure a highly functional department.
• Adheres to and enforces policies and applicable ethical, regulatory, and clinical standards.

Knowledge and Skills:

• Minimum of BS degree in Life Sciences, or other applicable scientific degree. MS , PhD or MD is preferred.
• 10+ years of applicable clinical research and medical writing experience in US, EU, and other international regulatory submissions in vaccines.
• 5+ years of line or matrix management experience (project and people management, management of overall resources).
• Significant experience in leading medical writing activities for major global submissions
• Scientific and medical expertise sufficient to understand and be conversant on key issues in relevant therapeutic areas.
• Highly advanced understanding of the clinical development process and preparation of the clinical sections of marketing applications and other regulatory submissions.
• Demonstrated excellence in leading global eCTD submissions, matrix leadership skills and strategic problem-solving ability.
• Expertise in global regulatory and compliance requirements and principles of global drug development from IND/CTAthrough submission, and ability to relate individual elements of clinical development programs to specific needs for document preparation and production.
• Expertise for all types of regulatory submission documents including but not limited to, Investigator Brochures and updates, clinical study reports, NDA/MAA eCTD summary documents, briefing documents, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents
• Advanced knowledge of ICH and GCP guidelines, and global regulatory requirements and processes as related to document content, organization, format, and production.
• Overall understanding of technologies required for document preparation and production, and ability to identify opportunities to implement value-added technology.
• Understanding of resources (time, headcount, expertise) and inputs required for preparation and production of documents supporting global regulatory submissions and global clinical development programs.
• Excellent oral and written communications skills and ability to communicate effectively across management, functional areas, and geographical locations.
• Ability to anticipate and manage the evolution of needs, and effectively drive the implementation of new technology and process to increase efficiency or address changes in requirements for document preparation and production.