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Senior Manager, Non-Clinical Regulatory Writer - Remote

Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: January 13, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionSenior Manager, Non-Clinical Regulatory WriterAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, Non-Clinical Regulatory Writer 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. As a Senior Manager in the Non-Clinical Regulatory Writing and Submissions (NRWS) group within Preclinical and Translational Sciences (PTS), you will be empowered to contribute to this science driven, collaborative and dynamic environment, bringing experience to add further value to the NRWS contribution to the PTS organization and to Takeda, with involvement in a variety of projects of diverse scope and complexity, reflecting the breadth of Takeda's portfolio (e.g., Oncology, Gastrointestinal, Neuroscience, Rare Disease). The NRWS team is a goal- and results-driven team, and we are strong believers in innovation and streamlined processes. A typical day will include:POSITION OBJECTIVES:

  • Manage mentor and develop team.
  • Involve in a variety of projects of diverse scope and complexity, across all developmental stages (pre-development through post-marketing) and Takeda's major therapeutic areas (e.g., Oncology, Gastrointestinal, Neuroscience, Rare Disease).
  • Author or review nonclinical sections of regulatory documents, such as Investigator's Brochures (IBs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs).
  • Analyze, interpret and distill nonclinical data to independently write and/or edit nonclinical documents. Ensure alignment with International Conference on Harmonization (ICH) guidelines, regulatory requirements and Takeda's policies and processes.
  • Author or review nonclinical technical reports. Summarize pharmacology, pharmacokinetics and toxicology data and prepare briefing packages for regulatory agency meetings or advice.
  • Apply advanced knowledge of relevant regulatory requirements and corporate policies, as well as work experience, to assess document requirements and identify information gaps or other potential issues.
  • Contribute to or prepare responses to requests for nonclinical information to worldwide health authorities.
  • Responsible for the planning and management of nonclinical regulatory submission components for compounds in Takeda's Research and Development portfolio.
  • Represent NRWS on cross-functional teams, and will lead the nonclinical submission sub-teams, working in close partnership with Global Regulatory Affairs (GRA) and nonclinical subject matter experts (SMEs) from pharmacology, drug metabolism and pharmacokinetics (DMPK), drug safety research and evaluation (DSRE) functions and external collaborators.
  • Provide nonclinical regulatory writing expertise and mentorship to members of NRWS. May lead or support training initiatives within the group and will support maintenance of a balanced workload among nonclinical writers.
  • May serve as the NRWS representative on cross-functional initiatives.POSITION ACCOUNTABILITIES:
    • Lead the planning, tracking, compilation and regulatory compliance of nonclinical documentation for regulatory submissions.
    • Representative on multiple project team across multiple therapeutic areas. For each assigned compound, manage all nonclinical content for global regulatory submissions.
    • Represent NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, GRA, Regulatory Operations) to plan, generate, manage, and finalize nonclinical documents for regulatory submissions. Generate nonclinical timelines. Liaise effectively with cross-functional team members to communicate aims, content requirements, and timelines.
    • Understand the principles of scientific writing, writing with the audience in mind and conveying messages in a clear and concise manner. Work closely with SMEs from DSRE, DMPK, Drug Discovery units and Therapeutic Area units to ensure appropriate input, review, and finalization of regulatory submission documentation activities in alignment with NRWS's policies and processes.
    • Learn and understand new therapeutic areas quickly and comprehensively.
    • Possess innovative problem-solving skills and ability to influence peers.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
      • Ph.D. in scientific field (e.g., biology, pharmacology, toxicology), with minimum of 4 years of experience with nonclinical and/or scientific writing within pharmaceutical or Contract Research Organization (CRO).
      • Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process.
      • Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions, including but not limited to IBs, briefing books, INDs, periodic reports, NDAs/MAAs/BLAs, and agency responses.
      • Experience with regulatory submissions for new modalities (eg: cell therapies, gene therapies, microbiome) is an advantage.
      • Experience in a program management-type role; ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and lead internal/external and scientific teams to regulatory submission aims.
      • Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g., FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements).Takeda U.S. Vaccine Requirement:Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.This job posting exclude Colorado applicants.WHAT TAKEDA CAN OFFER YOU:
        • 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.
          • RM-LIEEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsUSA - MA - Cambridge - VirtualSan Diego, CAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Cambridge , Senior Manager, Non-Clinical Regulatory Writer - Remote, Executive , Cambridge, Massachusetts

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