Posted to MedZilla on 9/22/2019


Takeda Pharmaceuticals

US-MA, Nonclinical Regulatory Submission Lead/Writer SR0040244-MZ


 
 

Summary

Responsible for the successful preparation of nonclinical components of regulatory submissions, including investigational applications, market applications, post approval variations, post approval reporting obligations, responses to regulatory queries, etc. Also accountable for the successful preparation, review and publishing of technical documents for which the department is responsible, eg, nonclinical study reports, nonclinical & clinical bioanalytical reports and related nonclinical/clinical bioanalytical CSR or regulatory submission sections/content. Prepare and maintain related document templates, plans and timelines. Collaborate effectively with relevant stakeholders, intra- and inter-departmental functional representatives, eg, in Regulatory, Clinical, Program Management, and program/project teams to ensure timely delivery of high quality, submission-ready submission components that are consistent with relevant regulatory guidelines for global submissions.

Responsibilities

  • 70% - Manage preparation, writing, review of nonclinical components of regulatory submissions and all technical documents for which the department is responsible. Ensure timely delivery of high quality, submission-ready submission components that are consistent with relevant regulatory guidelines for global submissions (eg, US FDA, EMEA, PMDA, ICH).
  • 20% - Collaborate effectively with relevant stakeholders, intra- and inter-departmental functional representatives and submission teams in coordinating development, review and hand-off of nonclinical sections of regulatory filings and clinical bioanalytical content to Regulatory Ops/Affair, Clinical Ops/Development/Medical Writing.
  • 10% - Develop and maintain documents templates and high quality systems for tracking of nonclinical components of regulatory submissions, nonclinical technical and nonclinical & clinical bioanalytical reports and related nonclinical/clinical bioanalytical sections/content for global regulatory submissions.

Education and Experience Requirements

  • College degree B.S./M.S. preferably in biology, pharmacology, toxicology, or related biomedical discipline. Minimum 4-6 years of experience in pharmaceutical or biotech product development with direct involvement in regulated studies related to pharmacology, toxicology, pharmacokinetics, etc.
  • Minimum 2 years experience in authoring nonclinical components of regulatory submissions.
  • Experience authoring nonclinical/clinical bioanalytical reports and related clinical documents preferred.

Key Skills, Abilities, and Competencies

  • Incumbent at this level will be involved in a variety of projects of diverse scope and complexity which require thorough and practical solutions.
  • Must have a thorough understanding of relevant regulatory guidelines for global submissions (eg, US FDA, EMEA, PMDA, ICH) and direct experience in the successful preparation of technical sections of investigational and marketed drug product applications.
  • Must have excellent attention to detail, organizational abilities, and written and verbal communication skills.

Required Skills:

  • Highly organized; proactive in identifying and developing solutions to problems; ability to simultaneously manage multiple tasks; works well under pressure.

Required Leadership Capabilities:

  • Excellent communications skills with colleagues at all levels; sense of urgency; good judgment; and a team player.

Complexity and Problem Solving

  • Works largely autonomously under general direction. Must be able to proactively identify issues and (in collaboration with others as needed) develop solutions to complex problems with cross-functional scope.
  • Work may be reviewed upon completion for adequacy in meeting objectives. Exercises good judgment within generally defined practices and policies in selecting methods and techniques.

Internal and External Contacts

  • Internal and external job contacts related to the position include NCD staff, cross-functional project/program teams and representatives, as well as colleagues in Regulatory (Ops, Affairs, CMC), Clinical (Ops, Development, Medical Writing), Program Management (R&D PM, SPPM), consultants, and senior management.

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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