Medical Writing Lead, Vaccine Business Unit

vor 2 Wochen

Fribourg, Schweiz Takeda Pharmaceutical Vollzeit

**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.**

The **Medical Writing Lead** is responsible for strategically planning and resourcing the medical writing (MW) deliverables that support Takeda’s business objectives for clinical development for VBU with multiple vaccines through all phases of development.

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

The Lead MW will be:

- Responsible for Medical Writing global submission timelines/planning/forecasting and budget management for assigned therapeutic area. Responsible for administrative budget and for direct reports
- Responsible for MW vendor oversight and operational strategy, contract compliance, quality and timeliness of deliverables, and continuous improvement related to outsourced clinical development MW activities.
- Responsible to write and assume primary responsibility for clinical regulatory documents to support filings

The Lead MW will have:

- Understanding and working knowledge of current global regulatory requirements/guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents
- Ability to interact effectively with team members to facilitate information exchange (including problem solving and issue resolution). Knowledge of team dynamics and ability to function as a team lead.
- Ability to integrate business and science to make strategic decisions.

The Lead MW will assume responsibility for medical writing issues relating to global development programs, and serve as responsible contact for team and functional managers. This is a leadership role that will be responsible for developing and implementing global medical writing strategies, operational plans and innovative solutions for all medical writing activities. They will lead high performing in-house and outsourced medical writing teams in the delivery of high quality regulatory writing services in accordance with applicable regulatory regulations. They will oversee the strategies that fully support global regulatory submissions and global clinical development programs with respect to content, processes, and standards, and enhance quality and optimize production time for all regulatory documents.

**ACCOUNTABILITIES**:

- Provides global medical writing strategic direction and leadership for VBU across multiple vaccines
- 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
- Responsible for developing, implementing and assuring execution of strategic global medical writing plans.
- Accountable for overall direction of multiple, large, complex regulatory submissions.
- Develops, reviews, approves and implements medical writing processes, standards, and templates.
- Guides medical writing activities (including document preparation and/or production) for assigned regulatory submissions or projects.

The activities of the Lead MW (performed with mínimal oversight) include, but are not limited to: writing, development of timelines, project management of deliverables, and participation on project teams.

In addition to program responsibilities, the Lead MW may lead or participate in departmental or cross-functional initiatives designed to establish highly efficient processes, best practices, and productive cross-functional collaboration.

The Lead MW may have responsibility for:

- mentoring of less experienced writers and oversight of external service providers
- coordinating the activities of Takeda and contract employees (on-site or external),
- providing review and substantive editing of contributions, and ensuring resolution of issues
- provide direction to and manage other writers (as needed) to ensure the timely delivery of high-quality documents that are scientifically rigorous and logically organized, with accurate data presentation and interpretation
- effectively delegate and intervene as required to maintain optimal productivity
- guide document preparation, including coordination of assignments to Takeda and contract writers, review, and substantive editing of documents
- The Lead MW may also participate in departmental and/or cross-functional initiatives and task forces.

**EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS**:

- Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree required; 7 to 10 years of experience in clinical/pharmaceutica

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