Posted to MedZilla on 6/17/2019


Takeda Pharmaceuticals

US-MA, CMC Submissions Lead SR0034841-MZ


 
 

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Shire Human Genetic Therapies Inc., a Takeda company, for the following job opportunity:

JOB LOCATION: Lexington, MA

POSITION: CMC Submissions Lead

POSITION DESCRIPTION: Shire Human Genetic Therapies Inc., a Takeda company, is seeking a CMC Submissions Lead to establish global submission activities and timelines in partnership with global and cross functional stakeholders in PD&TS, Biologics and Small molecule Operating Units, Regulatory Affairs and QA; contribute to broader improvement initiatives including strategy development, process enhancement, solicit feedback, tool development, and training roll out; utilize knowledge of global CMC regulatory submission requirements for small molecules, biologics, combination and/or plasma derived products and global requirements for submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES); execute global planning and tracking for CMC submission activities for franchise portfolio, ensuring appropriate stakeholder engagement and participation; support operational excellence for CMC regulatory submissions; perform day-to-day management of CMC regulatory submissions; enable high quality CMC documents through content review and compliance submission ready standards; track new and updated global regulatory requirements and proactively provides summaries and recommendations as appropriate; maintain awareness of current trends in regulatory requirements; utilize Shire EDMS system and provide support to end users to ensure effective utilization of document management systems; execute global planning and tracking of regulatory submissions using Electronic Document Management System (EDMS); manage preparation, compilation, and review of submission templates for timely filing of regulatory submissions; facilitate content verification of CMC submissions for Response to Agency Inquiries for biologics product; manage teleconferences with regulatory submissions representatives for pre-submission strategy and submission pathway development.

REQUIREMENTS:Bachelor s degree in Chemistry, Pharmacy, or related field plus 2 years related experience. Will accept any level of experience in the following required skills: execute global planning and tracking of regulatory submissions using Electronic Document Management System (EDMS); manage preparation, compilation, and review of submission templates for timely filing of regulatory submissions; facilitate content verification of CMC submissions for Response to Agency Inquiries for biologics product; manage teleconferences with regulatory submissions representatives for pre-submission strategy and submission pathway development.

Full time. $87,400.00 - $131,000.00/year. Competitive compensation and benefits.

Qualified applicants can apply at Takeda careers page at: https://www.takedajobs.com. Please reference job #R0034841. 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/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.


Please visit our website at takedajobs.com

 
 


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