Posted to MedZilla on 10/13/2019


Takeda Pharmaceuticals

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.

Responsibilities

  • Drug development documentation management

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.

  • Training management

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.

  • CTD Module 1 and Module 3 supporting document management

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.

  • Oversight of Data Integrity Checks

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.

  • General

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

  • Bachelor s degree in chemical or biological sciences or related field is required; advanced degree is desirable
  • Typically requires a minimum of 8 years of experience in the pharmaceutical industry or similar relevant environment
  • Experience in documentation and training management and proficiency in the use of associated electronic systems is strongly preferred
  • Experience in the preparation of submissions to regulatory agencies is desirable

Key Skills, Abilities, and Competencies

  • Strong communications skills, both written and verbal
  • Ability to assess workload and prioritize efforts
  • Detail oriented and articulate
  • Excellent organization skills
  • Ability to represent CMC Filing Group as a member of project teams
  • Strong team member with demonstrated ability to work collaboratively with others as well as being able to take initiative and exercise independent judgment
  • Proficient in use of Windows environment software with advanced skills in Microsoft Word and Excel

Complexity and Problem Solving

  • Ability to assess need, apply experience and develop solutions to complex issues and to determine and/or negotiate the most appropriate course of action in a timely manner
  • Ability to engage and influence a range of personnel, peers, and superiors with a collaborative style
  • Drive and energy to multi-task in a fast-paced environment, with flexibility and strength to navigate through crises

Internal and External Contacts

  • Job is accountable to the line manager. Liaises with internal cross-functional teams and external partners.

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

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.