Regulatory Process and Standards Lead - Lexington, MA



July 12, 2014

Primary Duties:
The Regulatory Process Standards Lead will further the vision for Global Regulatory Affairs (GRA) in alignment with the One Shire business model to establish and document global process and standards. This position will collaborate with all functions within GRA to design optimum Shire Regulatory processes and interfaces between GRA and Shire functions and contribute to the direction and implementation of GRA's standards and SOP strategy. Responsibilities: 70% Drives the development and update of GRA processes and standards:
*  Responsible to collaborate with GRA service leads, GRA professionals and Shire functions to develop, maintain, update and implement global (or regional) operational processes, standards and guidance documents for all GRA services as needed.
*  Work collaboratively with GRA leaders and cross-functional R&D representatives to ensure the global implementation of harmonized SOPs, processes and standards.
*  Alerts GR
A Process Standards and Training Director of significant deficiencies in process and procedural standards and recommends optimization and corrective action plans.
*  Identifies potential areas of process vulnerability and risk; recommends corrective action plans for resolution.
*  Responsible for the optimization of processes to support GRA's strategies globally and ensure that the company's regulatory programs are optimally designed and executed.
*  Accountable, directly or through matrix structure for GRA process optimization, including but not limited to:
*  Reviewing GRA process to identify opportunities for process improvement.
*  Providing input in process improvement.
*  Examining interfaces between GRA processes and processes of other functions within R&D to identify opportunities to improve the overall efficiency of Regulatory at Shire. 15%
*  Drives GRA -special projects- for the continuous improvement of GRA:
*  Responsible for leading the creative development of templates and tools for the use by GRA.
*  Responsible for leading or contributing to GRA continuous improvement efforts. 15% Other responsibilities:
*  Mentoring GRA employees/consultants.
*  Participating in interviewing, hiring and training employees/consultants.
*  Planning, assigning and directing work in a matrix environment.
*  Developing risk management plans and overseeing implementation.
*  Managing performance assessments and career development activities. Education and Experience Requirements Bachelor's degree in a scientific field is required (M.S. or Ph.D. preferred).
*  8 - 10 years of pharmaceutical experience in an R&D environment.
*  Generally has at least 3 years of project management experience in a matrix environment.
*  Experience in drug development strongly preferred.
*  Process consulting and/or documentation authoring experience strongly preferred. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Please apply at: Application URL:

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