Posted to MedZilla on 9/17/2019

Takeda Pharmaceuticals

US-MA, Principal Medical Writer, Associate Director SR0040012-MZ


Job Summary

The Clinical Scientific Writing (CSW) Principal (Associate Director) is responsible for strategically planning and resourcing the global medical writing deliverables that support Shire business objectives within a therapeutic program or across multiple programs, depending on the scope. The CSW Principal independently 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 Principal writes or provides direction and leadership 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 Principal 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 Principal contributes to the strategic direction and efficient functioning of the CSW department. The CSW Principal has responsibility for non-program-related activities, and will 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 Principal generally has responsibility for mentoring of less experienced writers and oversight of external service providers.

The CSW Principal (Associate Director) reports to the CSW Team Lead (Director) or to the CSW Head (Senior Director).


40% - Writes, most often the more strategic documents, to support the goals of the product(s)/program(s)

5% - Directs/mentors CSW staff and ensures quality and efficiency in the production of clinical regulatory documents

25% - Oversees the medical writing aspects of program(s): attends strategic meetings, develops timelines, assesses resource needs, collaborates with cross-functional colleagues

25% - Leads or participates in departmental or cross-functional initiatives

5% - Performs management activities, eg, oversight of external service providers

Education and Experience Requirements

  • Advanced degree in a relevant scientific/clinical/regulatory discipline preferred; Bachelor s degree required
  • 8+ years of experience in clinical/pharmaceutical development with 5+ years directly related medical/scientific writing experience
  • Global regulatory submission experience required

Key Skills, Abilities, and Competencies

  • Leadership and mentoring skills
  • Demonstrated ability to lead the development, review, and approval of all clinical regulatory document types (ie, those typically developed by CSW) and the ability to develop new or unique document types
  • Demonstrated ability to analytically evaluate and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical and therapeutic teams
  • Excellent project management skills including in-depth understanding of clinical timelines (study and submission level), working knowledge of the roles of other functional areas and interdependencies among groups; demonstrated ability to establish detailed timelines for completion of assigned projects and ensure efficient, timely completion
  • Demonstrated ability to appropriately manage resourcing across multiple projects with competing workload priorities
  • Strong oral and written communication skills
  • Ability to interact effectively with team members/leaders to facilitate information exchange (including problem solving and issue resolution)
  • Working knowledge of current global regulatory requirements/guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents
  • Experience with interpreting and applying global regulatory authorities regulations and/or guidance, including but not limited to: ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E)
  • Excellent working knowledge of writing-related computer software, templates, and electronic document management systems
  • Ability to contribute to therapeutic area strategic product development

Complexity and Problem Solving

  • Ability to work in an ever-changing environment; demonstrated ability to multitask and achieve deadlines and targets under time constraints
  • Ability to work on complex problems in which analysis situations require in-depth evaluation of various factors and result in solutions including implementation and training plans
  • Ability to work cross-functionally contributing to company-wide standards and processes

Internal and External Contacts

  • Internal contacts Document contributors, reviewers, approvers; R&D leadership and colleagues from all functional areas within R&D; Commercial/Marketing; Legal
  • External contacts External service providers and management; independent consultants; key opinion leaders

Other Requirements

  • Less than 10% travel (domestic or international)

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.

EEO is the Law -

EEO is the Law Supplement -

Pay Transparency Policy -

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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