Senior Manager, Nonclinical Regulatory Writer
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: March 12, 2023
Job Description:
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Job Description
Senior Manager, Nonclinical Regulatory Writer
Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as a Senior
Manager 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 Senior Manager working on the Nonclinical Regulatory Writing
and Submissions team, 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
.
POSITION OBJECTIVES:
- Manage, mentor and train members
- 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., pharmacokinetics,
pharmacology, toxicology), with minimum of 6 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) Base Salary Range: $101,500 -$145,000, based on
candidate professional experience level. Employees may also be
eligible for Short Term and Long-Term Incentive benefits as well.
Employees are eligible to participate in Medical, Dental, Vision,
Life Insurance, 401(k), Charitable Contribution Match, Holidays,
Personal Days & Vacation, Tuition Reimbursement Program and Paid
Volunteer Time Off.
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
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
Keywords: Takeda Pharmaceutical, Cherry Hill , Senior Manager, Nonclinical Regulatory Writer, Advertising , Cherry Hill, New Jersey
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