US-MA, Regulatory Documentation Manager SR0040024-MZ
The CMC Filing Group within R&D, Pharmaceutical Sciences is responsible for the creation of the content of regulatory submissions with the aim of expediting the approval of life-changing therapies.
The role of the CMC Filing Manager is to manage the drug development documentation process and system, manage the training process and system, manage the collection and storage of CTD Module 1 administrative documents and Module 3 ancillary documents, and oversee data integrity checks of regulatory submissions.
Apply experience and expertise in managing the process by which drug development documentation is created and archived. Provide leadership and guidance, and pioneer process and procedure improvement initiatives that enhance the quality of documents and the efficiency with which they are created. Documents include SOPs, Job Aids, technical protocols and reports, technical memos, and others. They may be generated internally or externally to Pharmaceutical Sciences and/or the company. Oversee and ensure compliance with document periodic review and retention requirements. Collaborate with appropriate functions to update and improve electronic document storage systems as needed. Provide assistance to electronic system users in the creation, review, or revision of documents and system searches.
Ensure that department training processes and procedures are compliant with all applicable requirements. Work with managers of all Pharmaceutical Sciences functions to create training curricula and ensure proper assignment of training in compliance with relevant requirements. Update and maintain the electronic training system and provide assistance to users.
Collaborate with CMC Submissions and Regulatory CMC and others to facilitate the collection and archiving of Module 1 and Module 3 supporting documents. These include administrative documents, literature references, reports, certificates, and others.
In concert with CMC Submissions, administer the process by which the content of regulatory submissions is verified against source documents to ensure accuracy. Provide content verification services as needed.
Provide organization support and project team participation including strategy meetings, information gathering, progress reports and presentations etc. Proactively seek input, feedback and assessment from key stakeholders to drive business improvements. Assist in the development and implementation of departmental processes, procedures and policies. Actively promote talent, knowledge sharing and collaborative spirit.
Education and Experience Requirements
Key Skills, Abilities, and Competencies
Complexity and Problem Solving
Internal and External Contacts
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
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