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Head, Nonclinical Regulatory Writing & Submissions

応募後で応募 求人ID R0020847 掲載日 06/24/2020 Location:Cambridge, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Global Head of Drug Safety Research and Evaluation in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission


The Head of Nonclinical Regulatory Writing & Submissions (NRWS) is responsible and accountable for the planning, tracking, compilation and delivery of all nonclinical documents encompassing the entire Takeda R&D portfolio for internal development programs and Global regulatory submissions. This includes the management of preclinical and translational science documents (research study/project reports), nonclinical development documents (study reports, summary documents) and all authored regulatory documentation supporting in‑line, pipeline and late stage programs.

The regulatory component of this role includes managing and integrating all research and nonclinical functional reports and supporting documentation into a regionally compliant format, in collaboration with the timeline and strategy mandated by the Takeda Global regulatory affairs and drug safety team. Additionally, this function supports Takeda Business and Center for External Innovation (CEI) by respectively and efficiently managing the documentation for nonclinical due diligence process, asset in-licensing and divestiture processes in compliance with R&D IT, Strategy & Operations and Quality Assurance processes.

The successful group leader is expected to maintain a flat, goal-driven team and to balance strategic considerations with tactical, detailed technical aspects in approaching and dealing with project/program or product-related regulatory submission issues. This lead serves as the PTS representative and primary stakeholder, providing expertise and alignment with internal operating processes and Global Regulatory and cross-functional initiatives.  This individual will be highly analytical and organized, decisive, goal- and customer -oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of NRWS develops and implements detailed plans for the compilation, QC, review, compliance approval and transfer to Regulatory Affairs of preclinical/translational and nonclinical generated documents for regulatory submissions across all global therapeutic area units (TAUs)/ drug development units (DDUs) and functional teams within PTS, including reports generated by CROs.

The incumbent will establish and maintain high value systems and procedures for training and maintaining quality standards for the format and content of nonclinical documents and is responsible for ensuring final submission-readiness and delivery of nonclinical documentation. Candidate will be a standing member in R&D IT initiatives that impact the PTS team and ensure awareness and inclusion of the NRWS function with cross-functional stakeholders. The Head, NRWS will also be a member of the PTS Leadership Team.


Scope of Essential Functions:

Comparative Medicine North America


Leadership, management, and oversight of the Nonclinical Regulatory Writing & Submissions group staff.

  • Conducts all line management and administrative function for the group; consistently evaluate group organizational structure, resource allocation and workload; provide prioritization of headcount needs, review job levels; initiate hiring and on-boarding/off-boarding
  • Responsible for all team member performance evaluations, career development planning and goal setting.
  • Maintains global team organizational structure with remote FT and consulting staff
  • Trains and mentors staff to foster development and expansion of collaborative roles and network; engage in cross-functional initiatives to support the Takeda organization
  • Demonstrates positive leadership-emphasize teamwork and commitment; provide encouragement and resolution to support staff in a highly dynamic environment
  • Regulatory provides updates in written and verbal format to team, leadership team and upper-level management / cross-functional teams to showcase milestones/success and tracking of deliverables

Lead the planning, tracking, compilation and regulatory compliance of all nonclinical documentation for regulatory submissions:

  • Regularly liaises with various cross-functional teams (Clinical, Global Patient Safety, Program Management) and stakeholders (Global Regulatory Affairs, Regulatory Operations) as well as PTS program-team representatives to maintain a current submissions schedule, strategy and understanding of nonclinical documentation needs.
  • Evaluates the capabilities and competencies of documentation vendors and consultants; is responsible for selection, training, oversight and resource allocation of third party vendors for process support in provision of work overflow at integration/divestment
  • Provides on-boarding training, system access and submission tools to enable Regulatory submission activity for PTS organization
  • Liaises efficiently and effectively with PTS functional leads and Regulatory Affairs/Operations to establish clear submission aims, content requirements and timelines
  • Leads documentation efforts and provide transparency of regulatory document lifecycle management to PTS organization on asset, platform and companywide integrations and divestments
  • Works closely with PTS function leads (DSRE, DMPK, QTS, etc) to ensure appropriate input, review, approval and sign-off of documentation activities.
  • Provides oversight and input to Drug Discovery Sciences and Discovery Research Therapeutic Area Teams (eg, Global Biologics) to manage transfer of Research reports required for submission into regulatory documents.

Responsible for developing and maintaining process and quality standards for the format and content of nonclinical documents.

  • Works closely with PTS functional leads, Drug Discovery Sciences team and Regulatory Operations to define/develop Takeda templates and standards for the format and content of nonclinical study reports and submission documents.
  • Maintains awareness of changes in global Regulatory Authority nonclinical documentation requirements/expectations and ensures that Takeda’s standards are compliant; provide training and ensure alignment for PTS teams
  • Develops and maintains processes to ensure that Takeda standards for documentation, document transfer, version control and archiving are applied within PTS and by external vendors.
  • Represents PTS on company wide documentation initiatives (eg, Global Core Dossier, EDMS, effective submission planning)
  • Oversight of system conformity, training adherence and alignment with GRA-IT (eg, EDMS maintenance of nonclinical documentation)
  • Represent the PTS organization as primary stakeholder in Global processes and initiatives that impact the PTS organization; provides both strategic and technical input on systems (eg, EDMS upgrades/harmonization) and software
  • Performs review of dossier/documentation and provides input within due diligence workstreams


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

  • 12 -15 years experience working in nonclinical sciences within the pharmaceutical industry
  • 10 years experience managing and compiling nonclinical documentation or regulatory submissions.
  • Expertise in written and spoken English is required.
  • Masters degree in a scientific field or related subject.

•    401(k) with company match and Annual Retirement Contribution Plan
•    Tuition reimbursement Company match of charitable contributions
•    Health & Wellness programs including onsite flu shots and health screenings
•    Generous time off for vacation and the option to purchase additional vacation days
•    Community Outreach Programs

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Cambridge, MA

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Full time