US-MA, Principal Medical Writer 1700191-MZ
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 a Principle Medical Writer in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring and bold mission. As a Principle Medical Writer, you will be empowered to lead the preparation of key regulatory response documents for a designated therapeutic or functional area and a typical day will include:
Within a designated therapeutic or functional area, leads a single team which formulates the writing strategy for key response documents and regulatory submissions Guides medical writing document preparation, including coordination of assignments to Takeda and contract writers, review and substantive editing of documents.
As necessary, may assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission. Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area.
Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation, including US and international regulatory guidance and requirements for content and format, Takeda requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
Leverages internal and external resources to achieve quality, timely and cost-effective compound level submission deliverables. Participates in the training, guidance, and mentoring of the medical writing junior staff and may oversee junior staffs deliverables.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
WHAT TAKEDA CAN OFFER YOU:
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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