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Shire Regulatory Tech & IM Manager in Cambridge, Massachusetts
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Takeda Human Genetic Therapies Inc. for the following job opportunity:
JOB LOCATION: Cambridge, MA
POSITION: Regulatory Tech & IM Manager
POSITION DESCRIPTION: Takeda Human Genetic Therapies Inc. is seeking a Regulatory Tech & IM Manager with the following duties: provide technical and business support to the Global R&D users that are using the Global Regulatory Systems and Applications; ensure that GRA requirements are incorporated and supported by both new systems and also upgraded to existing systems, in partnership with R&D IT; provide recommendations in formulating new technology and guidance; Provide Business User support and recommendations on the structure and preparation of electronic regulatory specifications and submissions and the ability of publishing tools and systems to support them; represent Global Regulatory Affairs (GRA) as a Subject Matter Expert, providing both business and technical solutions for GRA systems, developing and maintaining supporting information related to the use of GRA systems, e.g. system job aid/ help guide; collaborate with the respective R&D Information Technology teams to drive the development and update of Global Regulatory requirements, processes and standards; establish, update and implement Regulatory required formats, templates, policies, standards, and procedures for regulatory submissions; maintain up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, IDMP; publish standards and analyze new and revised guidance, advice regulatory management of new requirements, and recommend course of action; provide recommendations on the approach for the application of expert knowledge of global regulatory; ensure budgets, schedules and performance requirements are met; act as subject matter expert (SME) for GRA System; provide technical and business support for R&D systems; manage support, troubleshooting and communicate with business; act as key contact from IT for business; identify solutions for critical business needs; perform process development methodologies specific to Pharma and validated systems.
REQUIREMENTS: Bachelor's degree in Engineering, Computer Science or related field plus 6 years related experience. Will accept any level of experience in the following required skills: act as subject matter expert (SME) for GRA System; provide technical and business support for R&D systems; manage support, troubleshooting and communicate with business; act as key contact from IT for business; identify solutions for critical business needs; perform process development methodologies specific to Pharma and validated systems.
Full time. $108,000.00 - $146,000.00/year. Competitive compensation and benefits.
Qualified applicants can apply directly to the Takeda careers page at: https://jobs.Takeda.com. Please reference job #R0029182. EOE
Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.
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 - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.