Posted to MedZilla on 9/16/2019


Takeda Pharmaceuticals

US-MA, Manager, GRA CMC Submissions Management SR0040828-MZ


 
 

The Manager of GRA CMC Submission Management (CSM) R&D drives the Global CMC Submissions Team for Development submissions (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Post-Approval Changes for where R&D deliverables are needed for commercial/GMS regulatory submissions the Research and Development (R&D) Division by managing a team of subject matter experts including Pharmaceutical Sciences representatives, Quality representatives, and cross-functional stakeholders in Regulatory. The manager establishes the document plan, negotiates timelines with authors, drives all deliverables against the timeline, compiles all submission ready documents, and delivers the final submission components to the Publishing team. Where R&D deliverables are needed for commercial/GMS regulatory submissions, the Manager collaborates with the CSM Lead in Global Manufacturing and Supply (GSM) to prioritize documents, drive the timeline and manage the R&D stakeholders. The Manager ensures all deliverables are prioritized and tracked and delivered on time, escalates issues where they are identified, and provides strategic insight on issue resolution.

ACCOUNTABILITIES:

  • Maintain doc plan / timeline
  • Develop TOC aligned with Reg-CMC strategy
  • Collaborate with Reg-CMC and Content owners to prioritize and align deliverables
  • Establish document structure
  • Create vdoc and applicable templates
  • Author management
  • Drive meetings for kickoff, round tables, content / data reconciliation, and follow-ups
  • Lead RTQ process (e.g., Rapid Response Team)
  • Maintain content verification / approval workflow
  • Document management
  • QC, formatting, uploading, filing history, headers / footers, linking, and folder / vdocstructure
  • Document legalization, as needed
  • Issue resolution and mitigation planning activities
  • Manage submission readiness
  • Content verification and the final quality check
  • Prepare deliverables for support of submissions
  • Transfer TOCs
  • Provide submission ready docs to publishing
  • Archive necessary documents

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • 4+ years pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
  • Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents) is essential
  • Demonstrates attention to detail and problem-solving abilities.
  • Exercises appropriate judgement when working with project teams.
  • Exercises good judgement in elevating and communicating actual or potential issues to line management.
  • Excellent written and oral communication skills required.

PHYSICAL DEMANDS:

  • Routine demands of an office based environment.
  • Manual dexterity required to operate office equipment (ie computers, phones, etc)

TRAVEL REQUIREMENTS:

  • Ability to attend offsite meetings that may involve overnight stay

ADDITIONAL US SPECIFIC INFORMATION:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • 4+ years pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance).

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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