Senior Manager, GRA, Global Compliance
Company: Takeda Pharmaceutical
Location: East Bridgewater
Posted on: May 16, 2022
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Job Description:
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to the best of my knowledge.Job
DescriptionOBJECTIVES/PURPOSEWorking with GRA Compliance leadership
and key stakeholders, manage the program for the tracking,
implementation, execution, and reporting of GRA processes and
responsibilities that drive excellence in pre and post submission
activities. Partners with internal stakeholders and external CRO
partners such as Global Regulatory Compliance, IT, Global
Regulatory Operations, Labeling, GPSE, Regulatory Therapeutic
Areas, and Local Operating Companies for successful Regulatory
Affairs compliance management of clinical trials. Support process
change management, communication/training, completion of CAPAs/QEs,
and audit and Inspection support of GRA
responsibilities.ACCOUNTABILITIESWith Global Compliance leadership,
provides Global Compliance support for inspections and audits:
Ensure inspection readiness Coordinates documentation requests
prior to, during and in follow up to inspections and audits on
behalf of Regulatory Affairs Supports the development of responses
and CAPAs related to Regulatory Affairs for audits/inspections
Escalate issues/problems to management as needed Maintains strong
knowledge of current regulations, legislation, best practices and
guidelines relating to Regulatory Affairs. Represents GRA
Compliance on strategic initiatives impacting Regulatory Affairs
systems and processes. Supports work on business partner agreements
related to labeling activitiesCORE ELEMENTS RELATED TO THIS
ROLEStrong knowledge of the regulatory requirements in major
markets like EU, USA, Canada, U.K. and other international markets.
This role is global and has cross-functional colaboration across
multiple parts of the Regulatory, Regulatory Compliance, Quality
and R&D groups including TAU, MPG, Global Labeling, Labeling
Operations and CROs. Quality System Management and Regulatory drug
development experience is key for this role to be successful.
Systems Knowledge -knowledge of Quality Management Systems,
including Deviation (Trackwise) systems, SharePoint, and Regulatory
Information Management (RIM).DIMENSIONS AND
ASPECTSTechnical/Functional (Line) ExpertiseComprehensive
understanding of the pharmaceutical industry and the labeling
regulatory requirements. Comprehensive understanding of the
Regulatory Compliance function.Leadership (Vision, strategy and
business alignment, people management, communication, influencing
others, managing change)Demonstrated ability to work across
functions, regions and cultures Excellent communicator, able to
persuasively convey both ideas and data, verbally and in writing
Proven skills as an effective team player who can engender
credibility and confidence within and outside the company Embraces
and demonstrates a diversity and inclusion mindset and role models
these behaviors for the organization Invests time in helping others
to enhance their skills and perform at a higher
levelDecision-making and AutonomyDecision making responsibilities:
Provide input to highly complex decisions that impact the
functional area Accountable for providing input to and implementing
vision and strategy for designated scopeInteractionEffectively
navigates the changing external and internal environment and leads
others through change by creating and inspiring and engaging
workplace Cultivates a broad network of relationships throughout
Takeda, with affiliates and external partners, in the industry and
area of expertise. Ability to build strong relationships and
collaborate effectively with other interfacing Takeda
functionsInnovationComfortable challenging the status quo and
bringing forward innovative solutions Ability to take risks
implementing innovative solutions, accelerating time to market
Identifies opportunities and anticipates changes in the business
landscape through an understanding and ongoing assessment of the
environment affecting the business.ComplexityAbility to work in a
global ecosystem (internal and external) with a high degree of
complexityEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Bachelor's
degree (or equivalent) required. Masters preferred. 6 plus years'
experience in Pharmaceutical industry, with exposure to Regulatory
Affairs, labeling, and/or quality assurance/compliance (or
equivalent). Familiarity with inspections and audit procedures
Ability to identify risk of non-compliance in a complex environment
Practical operational experience of working across disciplines and
across multiple regions. Experience working within a global team
framework and a multi-cultural environment. Able to manage both
time and priority constraints and to manage multiple priorities
simultaneouslyEEO 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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Boston , Senior Manager, GRA, Global Compliance, Executive , East Bridgewater, Massachusetts
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