13 days old

Nonclinical Senior Writer-Quality Control Reviewer

Takeda Development Center Americas, Inc.
Boston, MA 02109
  • Job Code
    R0069597
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Job Description

Nonclinical Senior Writer-Quality Control Reviewer

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Nonclinical Senior Writer-Quality Control Reviewer 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 Nonclinical Senior Writer-Quality Control Reviewer in the Nonclinical Regulatory Writing and Submissions (NRWS) group within Preclinical and Translational Sciences (PTS), you will be empowered to contribute to this 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 (eg, Oncology, Gastrointestinal, Neuroscience, Rare Disease). The NRWS team is a goal- and results-driven team, and we are strong believers in innovation and streamline processes.

POSITION OBJECTIVES:

  • Ensure comprehensive quality check (QC) review of 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), briefing packages for regulatory agency meetings/advice, including verification of all references and source data, to achieve the highest quality from a technical, regulatory, and compliance perspective. Verify internal consistency within a document and across related documents.
  • Provide support for the writing, editing, QC, formatting, and publishing of nonclinical documentation and regulatory submissions in accordance with International Conference on Harmonization (ICH) guidelines, agency requirements, and Takeda's policies and processes.
  • Review, edit, and data verify nonclinical technical reports and publications in collaboration with subject matter experts (SMEs) and contributing NRWS staff.
  • 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.
  • Support responses to requests for nonclinical information to worldwide health authorities.
  • Manage nonclinical regulatory submission components for compounds in Takeda's Research and Development portfolio, including initiating and participating in electronic workflows in the appropriate electronic document management systems.
  • Participate on cross-functional teams and nonclinical submission sub-teams, working in close partnership with Global Regulatory Affairs (GRA) and nonclinical SMEs from pharmacology, drug metabolism and pharmacokinetics (DMPK), drug safety research and evaluation (DSRE) functions and external collaborators.
  • 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 (eg, Oncology, Gastrointestinal, Neuroscience, Rare Disease).
  • May serve as the NRWS representative on cross-functional initiatives.

POSITION ACCOUNTABILITIES:

  • Representative on multiple project team across multiple therapeutic areas. For each assigned compound, responsible for all nonclinical QC 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.
  • Work with NRWS writers to generate nonclinical timelines and collaborate effectively with cross-functional team members to communicate aims, content requirements, and timelines.
  • 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.
  • Manage and adhere to established timelines and communicate to management regarding any delay or issues with review.
  • Learn and understand new therapeutic areas quickly and comprehensively.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • M.S. in scientific field (eg, biology, pharmacology, toxicology), with minimum of 5 years of industry experience with 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.
  • Ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and support internal/external and scientific teams to regulatory submission aims.
  • Thorough understanding of regulatory guidelines related to global submissions and submission content (eg, FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements).
  • Keen attention to detail in reviewing and editing technical documentation.
  • Experience with regulatory submissions for new modalities (eg, cell therapies, gene therapies, microbiome) is an advantage.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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 Programs

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

*KB-LI

EEO Statement

Takeda 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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2022-06-17 Expires: 2022-07-16
Sponsored by:
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Sponsored by:
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Nonclinical Senior Writer-Quality Control Reviewer

Takeda Development Center Americas, Inc.
Boston, MA 02109

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