Head, Nonclinical Regulatory Writing & Submissions
Company: Takeda
Location: Somerville
Posted on: January 12, 2021
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Job Description:
By clicking the ---Apply--- button, I understand that my
employment application process with Takeda will commence and that I
agree with Takeda---s Privacy Notice, Privacy Policy and Terms of
Use.Job DescriptionOBJECTIVES: The Head of Nonclinical Regulatory
Writing & Submissions (NRWS) will report directly to the Head of
Takeda---s Preclinical and Translational Sciences (PTS) group. The
PTS group also includes pharmacology, drug metabolism and
pharmacokinetics (DMPK), drug safety research and evaluation
(DSRE), quantitative translational sciences (QTS), comparative
medicine and operational functions. This individual will be
responsible and accountable for:Leadership and management of the
NRWS team as well as the planning, tracking, compilation and
delivery of all nonclinical documents encompassing the Takeda
R&D portfolio for internal development programs and Global
regulatory submissions. This includes the management of all
nonclinical documents generated by the PTS group, such as
nonclinical study reports, summary documents, and all authored
regulatory documentation supporting programs throughout the
project---s lifecycle (pre-development through post-marketing).NRWS
representation on the PTS leadership team. Serve as a primary
stakeholder, providing expertise and alignment with internal
operating processes and Global Regulatory and cross-functional
initiatives. The Head of NRWS develops and implements detailed
plans for the compilation, QC, review, compliance approval and
transfer to Regulatory Affairs of preclinical/translational and
nonclinical generated documents for regulatory submissions across
all global therapeutic area units (TAUs)/ drug development units
(DDUs) and functional teams within PTS, including reports generated
by contract research organizations.Maintaining and supporting an
engaged, goal-driven team and balancing strategic considerations
with technical aspects in resolving regulatory submission
issues.Establishing and maintaining systems and procedures for
training and maintaining quality standards for the format and
content of nonclinical documents and is responsible for ensuring
final submission-readiness and delivery of nonclinical
documentation. The candidate will be a standing member in R&D
IT initiatives that impact the PTS team and will ensure awareness
and inclusion of the NRWS function with cross-functional
stakeholders.Supporting the Takeda Business and Center for External
Innovation (CEI) by efficiently managing the documentation for the
nonclinical due diligence process, asset in-licensing and
divestiture processes in compliance with R&D IT, Strategy &
Operations and Quality Assurance processes.ACCOUNTABILITIES: Job
Function and Description20%Leadership, management, and oversight of
the Nonclinical Regulatory Writing & Submissions group
staff.Conducts line management and administrative function for the
group; consistently evaluating group organizational structure
(including FTE and contract/consulting staff), resource allocation
and workload; provide prioritization of headcount needs, review job
levels; initiate hiring and onboarding/offboardingResponsible for
career development planning, goal setting, and performance
evaluation of direct reports.Trains and mentors staff to foster
development and expansion of collaborative roles and network;
engages in cross-functional initiatives to support the Takeda
organizationDemonstrates positive leadership - emphasizes teamwork
and commitment; provides encouragement and resolution to support
staff in a highly dynamic environmentRegularly provides updates in
written and verbal format to PTS leadership team and upper-level
management / cross-functional teams to showcase milestones/success
and tracking of deliverables60%Lead the planning, tracking,
compilation and regulatory compliance of all nonclinical
documentation for regulatory submissions:Regularly liaises with
various cross-functional teams (Clinical, Global Patient Safety,
Program Management) and stakeholders (Global Regulatory Affairs,
Regulatory Operations) as well as PTS project-team representatives
to maintain a current submissions schedule, strategy and
understanding of nonclinical documentation needsEvaluates the
capabilities and competencies of documentation vendors and
consultants; is responsible for selection, training, oversight and
resource allocation of third-party vendors for process support in
provision of work overflow Provides on-boarding training, system
access and submission tools to enable Regulatory submission
activity for PTS organizationLiaises effectively with PTS
functional leads and Regulatory Affairs/Operations to establish
clear submission aims, content requirements and timelinesLeads
documentation efforts and provides transparency of regulatory
document lifecycle management to PTS organization on asset
in-licensing and divestmentsWorks closely with PTS function leads
(DSRE, DMPK, QTS, etc) to ensure appropriate input, review,
approval and sign-off of documentation activitiesProvides oversight
and input to Drug Discovery Sciences and Discovery Research
Therapeutic Area Teams (eg, Global Biologics) to manage transfer of
Research reports required for submission into regulatory
documents20%Responsible for developing and maintaining process and
quality standards for the format and content of nonclinical
documents.Works closely with PTS functional leads, Drug Discovery
Sciences team and Regulatory Operations to define/develop Takeda
templates and standards for the format and content of nonclinical
study reports and submission documents.Maintains awareness of
changes in global Regulatory Authority nonclinical documentation
requirements/expectations and ensures that Takeda---s standards are
compliant; provides training and ensures alignment for PTS
teamsDevelops and maintains processes to ensure that Takeda
standards for documentation, document transfer, version control and
archiving are applied within PTS and by external vendors.Oversight
of system conformity, training adherence and alignment with GRA-IT
(eg, EDMS maintenance of nonclinical documentation)Serves as NRWS
primary stakeholder in Global processes and initiatives that impact
the PTS organization; provides both strategic and technical input
on systems (eg, EDMS upgrades/harmonization, Global Core Dossier,
effective submission planning)Performs review of
dossier/documentation and provides input within due diligence
workstreamsSCOPE OF SUPERVISION:Will provide a combination of
direct and indirect supervision for the group of 19
individualsEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List
the essential and desirable education and competency requirements
to perform the primary responsibilities of the job. Any minimum
requirements should be highlighted.)Bachelors or Masters degree in
a scientific field or related subject.At least 10 years---
experience working in nonclinical sciences within the
pharmaceutical industryAt least 5 years--- experience compiling
nonclinical documentation or regulatory submissions.Fluency in
written and spoken English is required.Key Skills, Abilities, and
CompetenciesProven leadership skills with individuals having a wide
range of experienceA broad understanding of the drug development
process and a thorough understanding of regulatory requirements for
the format, content and quality of nonclinical
documentation.Experience in process change and/or leading cross
functional initiativesHighly effective organizational and planning
skill.Effective interpersonal, oral and written communication
skillsMust be motivated, creative, energetic, resourceful and
adaptable, responding constructively to challenging new ideas,
information, situations or criticismQuickly learn technical
components of systems & software to contribute to process review
and create efficiencies to support staffAbility to effectively
engage with a wide variety of internal/external technical and
business experts in a respectful and transparent fashionComplexity
and Problem SolvingAbility to quickly and efficiently resolve
planning conflicts, manage multiple projects simultaneously and
deal with rapidly changing prioritiesEmphasize real-time
communication, accountability and trust within departmentDevelop
strategies for nonclinical submissions with relevant project teams
and PTS functional leads, and obtain line alignment and
approvalNotify line management of significant deviations from
plansAbility to rapidly assimilate/synthesize data and information
from diverse sources, make judgments on complex/abstract problems
and develop innovative solutions as necessaryInternal and External
ContactsAccountable to Head of PTS and routine interaction with
heads of PTS functional groups (eg: DMPK, DSRE, QTS). Engagement
and frequent contact required with the following internal and
external groups:Internal: Staff within PTS, Pharmaceutical
Sciences, Regulatory Affairs, Regulatory Operations, Clinical
Development, Clinical Operations, Project Management, Center for
External Innovation, Quality Analytical Compliance, Global Patient
Safety and others. Non-R&D staff in Process Development,
Quality Legal, Finance, others as needed.External: PTS
vendors/CROs, scientific experts, contractors & consultants.Must be
customer-orientated with a good awareness of customer
expectationsWHAT 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.LI-DA1LocationsCambridge, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time Full time
Keywords: Takeda, Somerville , Head, Nonclinical Regulatory Writing & Submissions, Other , Somerville, Massachusetts
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