Associate Director, Nonclinical Regulatory Writing and Submission Support
Company: Takeda Pharmaceutical
Location: Boston
Posted on: September 30, 2024
Job Description:
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in my employment application is true to the best of my
knowledge.Job DescriptionAssociate Director, Nonclinical Regulatory
Writing and Submission Support, Gastrointestinal and Inflammation
(GI2) and Neuroscience (NS) ProductsAt Takeda, we are a
forward-looking, world-class R&D organization that unlocks
innovation and delivers transformative therapies to patients. By
focusing R&D efforts on three therapeutic areas and other
targeted investments, we push the boundaries of what is possible in
order to bring life-changing therapies to patients worldwide.Are
you looking for a patient-focused, innovation-driven company that
enables you to engage in meaningful work? Join us as an Associate
Director - Nonclinical Regulatory Writer and Submission Support
reporting to the Nonclinical Regulatory Writing and Submission
Support, GI2 and NS Products Team lead, based in Cambridge,
MA/Virtual.Here, you will be a vital contributor to our inspiring,
bold mission.As an Associate Director in the Nonclinical Regulatory
Writing and Systems (NRWS) Department within Preclinical and
Translational Sciences (PTS), you will be contributing 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, including Oncology (ONC), GI2, and NS. The NRWS
team is a goal- and results-driven team, and we are strong
believers in innovation and streamlined processes.How you will
contribute:ACCOUNTABILITIES -
- Provides nonclinical regulatory writing expertise and
mentorship to NRWS and Research and Development (R&D) staff
members.
- Involves 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 with
focus on Gastrointestinal and Inflammation (GI2) and Neuroscience
(NS) Products across Takeda's portfolio.
- Applies advanced knowledge and experience to assess document
requirements, develop writing strategy, compose drafts, identify
information gaps or other potential issues, and facilitate document
finalization for submissions.
- Plans, authors, revises, updates and manages nonclinical
components of regulatory documents such as Briefing Books (BB),
Investigational New Drug Applications (INDs), Clinical Trial
Applications (CTAs), Investigator's Brochures (IBs), New Drug
Applications (NDAs), Biologic License Applications (BLAs),
Marketing Authorization Applications (MAAs), responses to queries
(RTQs), various annual reports (DSUR, DSUR, PBRER) and nonclinical
technical reports for drug products across Takeda's R&D
portfolio (preclinical through marketed) and Takeda's major
therapeutic areas with a focus on GI2 and NS programs across all
drug develement phases.
- Analyzes, interprets and distills nonclinical data to
independently write and/or edit nonclinical documents. Ensures
alignment with International Conference on Harmonization (ICH)
guidelines, regulatory requirements and Takeda's policies and
processes.
- Applies advanced knowledge of relevant regulatory requirements
and corporate policies, as well as work experience, to ensure
regulatory compliance by assessing document requirements and
identify information gaps or other potential issues.
- Leads nonclinical submission working groups to liaise
effectively with cross-functional team members (Clinical, Global
Patient Safety, Program Management, Global Regulatory, Regulatory
Operations, Drug Discovery Units, DMPK&M, and Drug Safety
Research and Evaluation) to recognize aims, align on strategy,
define executable timelines, and agree upon content for nonclinical
regulatory submissions.
- Represents NRWS on cross-functional project teams to plan and
communicate about nonclinical regulatory submissions.
- Understands and applies the principles of regulatory writing
and lean authoring, writing with the audience in mind and conveying
messages in a clear and concise manner when presenting
pharmacology, pharmacokinetics and toxicology data and
strategies.
- Serves as the NRWS representative on cross-functional
initiatives, when required.
- Develops practical timelines (Microsoft Project) for
deliverables.Minimum Requirements/Qualifications:
- Ph.D. in scientific field (e.g., pharmacokinetics,
pharmacology, toxicology), with minimum of 10 years of leadership
experience with nonclinical regulatory writing within a
pharmaceutical company 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 to queries.
- Experience in drug product development across numerous
modalities (small molecule, biologics, cell therapies, etc.),
demonstrating a broad understanding of the drug development process
(from preclinical through post-marketing stages). -
- Experience in a program management, with ability to prioritize,
manage multiple programs within strict regulatory/compliance
deadlines, and lead internal/external and scientific teams to
regulatory submission aims.
- Possess innovative problem-solving skills and develop ability
to impact outcomes through influence, not direct authority.
- Thorough understanding of regulatory guidelines related to
global submissions and submission content (e.g., FDA/EMA/PMDA
regulations; ICH guidance; GLP/GCP requirements; SEND requirements,
etc.).
- Regulatory Affairs Credential (RAC-Drugs) is an advantage.
- Strong verbal, written, and interpersonal communication
skills.
- Learning and understanding new therapeutic areas and regional
regulatory requirements quickly and comprehensively.
- Demonstrated ability to work in a global ecosystem (internal
and external) with a high degree of complexity.
- Demonstrated ability to see and understand a broader,
enterprise level perspectiveADDITIONAL INFORMATION
- The vast majority of project meetings are scheduled based on
Eastern Time standard working hours (8am - 5pm ET).
- Although this position is remote, occasional face-to-face
meetings may be important to attend (no more than quarterly, likely
in Boston, MA).Takeda Compensation and Benefits SummaryWe
understand compensation is an important factor as you consider the
next step in your career. We are committed to equitable pay for all
employees, and we strive to be more transparent with our pay
practices. -For Location:Massachusetts - VirtualU.S. Base Salary
Range:$149,100.00 - $234,300.00The estimated salary range reflects
an anticipated range for this position. The actual base salary
offered may depend on a variety of factors, including the
qualifications of the individual applicant for the position, years
of relevant experience, specific and unique skills, level of
education attained, certifications or other professional licenses
held, and the location in which the applicant lives and/or from
which they will be performing the job.---The actual base salary
offered will be in accordance with state or local minimum wage
requirements for the job location. -U.S. based employees may be
eligible for short-term and/ or long-term incentives. U.S. based
employees may be eligible to participate in medical, dental, vision
insurance, a 401(k) plan and company match, short-term and
long-term disability coverage, basic life insurance, a tuition
reimbursement program, paid volunteer time off, company holidays,
and well-being benefits, among others. U.S. based employees are
also eligible to receive, per calendar year, up to 80 hours of sick
time, and new hires are eligible to accrue up to 120 hours of paid
vacation. -EEO 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.LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
#LI-Remote
Keywords: Takeda Pharmaceutical, Boston , Associate Director, Nonclinical Regulatory Writing and Submission Support, Executive , Boston, Massachusetts
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