Posted to MedZilla on 11/22/2019

Takeda Pharmaceuticals

US-MA, Lead Medical Writer SR0040459-MZ


The Clinical Scientific Writing (CSW) Lead is responsible for medical writing activities that support Shire business objectives within a therapeutic program (eg, one or more products or indications, depending on the scope). The CSW Lead provides strategic direction to cross-functional project teams to ensure that clinical regulatory documents (eg, investigator s brochures, study protocols and amendments, study reports, clinical/integrated summaries, clinical overviews, contributions to briefing documents, response documents, and other IND/CTA or global regulatory submission documents as appropriate) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of clinical data are maintained from concept to licensing and disclosure. The CSW Lead writes or provides direction to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous and logically organized, with accurate data presentation and interpretation.

The activities of the CSW Lead (performed with minimal oversight) include, but are not limited to: writing, development of timelines, project management of CSW deliverables, and participation on project teams. In addition to program responsibilities, the CSW Lead may lead or participate in departmental or cross-functional initiatives designed to establish highly efficient processes, best practices, and productive cross-functional collaboration. Although the role does not include direct people management responsibilities, the CSW Lead may have responsibility for mentoring of less experienced writers and oversight of external service providers.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.