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Regulatory Nonclinical Writer, Associate Director

応募後で応募 求人ID R0069032 掲載日 06/20/2022 Location:Boston, Massachusetts; Remote

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Job Description

Regulatory Nonclinical Writer, Associate Director

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Regulatory Nonclinical Writer, Associate Director based remotely.

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 Regulatory Nonclinical Writer, Associate Director working on the NRWS team, you will be empowered to manage, mentor, and develop a team of junior nonclinical writers.

A typical day will include:

POSITION OBJECTIVES:

  • Lead or support training initiatives within the group and support maintenance of a balanced workload among nonclinical writers.
  • Analyze, interpret and distill nonclinical data to independently manage 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 Diseases) while ensuring alignment with International Conference on Harmonization (ICH) guidelines, regulatory requirements and Takeda's policies and processes.
  • Responsible for the planning, authoring, review, and management of nonclinical regulatory submission components or 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) for compounds across Takeda's Research and Development portfolio and Takeda's major therapeutic areas (e.g., Oncology, Gastrointestinal, Neuroscience, Rare Disease) in a variety of projects of diverse scope and complexity, across the different developmental stages
  • Lead the authoring and/or reviewing of preclinical and translational science regulatory documents (research study/project reports), nonclinical development documents (study reports) and the nonclinical sections (pharmacology, pharmacokinetics, and toxicology) in regulatory documentation supporting in-line, pipeline and late-stage programs.
  • Provide support and guidance on the nonclinical regulatory strategy and requirements for regulatory interactions, when needed.
  • Apply advanced knowledge of relevant scientific expertise, regulatory requirements, corporate policies, and work experience to assess document requirements and identify information gaps or other potential issues.
  • Support 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 Takeda processes.
  • Represent NRWS on cross-functional teams and work closely with Nonclinical technical Writing team and other internal and external collaborators.
  • Serve as the NRWS representative on cross-functional initiatives.

POSITION ACCOUNTABILITIES:

  • Independently lead the planning, tracking, compilation, and regulatory compliance of nonclinical scientific and technical documentation.
  • In collaboration with Takeda regulatory, lead the nonclinical regulatory strategy and provide the nonclinical organization with information on the regulatory requirements as needed.
  • Deep understanding of the scientific writing principles; writing with the audience in mind, and demonstrate an ability to conveying messages in a clear and concise manner.
  • Work closely with SMEs to ensure appropriate input, review, and finalization of technical documentation activities in alignment with internal policies and processes, and regulatory requirements.
  • Represent NRWS on cross-functional teams to plan, generate, manage, and finalize nonclinical documents. Generate nonclinical timelines.
  • Liaise effectively with cross-functional team members to communicate aims, content requirements, internal Takeda requirements, and timelines.
  • Learn and understand new therapeutic areas quickly and comprehensively.
  • Support NRWS and Takeda’s innovation initiative, as needed.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Ph.D. in a scientific field (e.g., biology, pharmacology, toxicology), with a minimum of 10 years of experience with nonclinical and/or scientific writing within a pharmaceutical or Contract Research Organization (CRO) is a must.
  • 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.
  • An experience in translational science is an advantage.
  • Significant experience in direct authoring of technical reports (pharmacology, toxicology, pharmacokinetics) is a must.
  • Experience with nonclinical summary sections to support regulatory submissions, including but not limited to IBs, briefing books, INDs, periodic reports, NDAs/MAAs/BLAs, and agency responses is highly preferred.
  • Experience with regulatory submissions for new modalities (e.g.: cell therapies, gene therapies, microbiome) is an advantage.
  • Demonstrate ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and lead internal/external and scientific teams to regulatory submission aims.

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

#LI-Remote

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