Senior Manager, GRO Regulatory Information Management, Hybrid / Remote
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Job Description
About the role:
At 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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Senior Manager, GRO Regulatory Information Management where you will be a key contributor responsible for strategic thinking, and expert execution for the Information Management portfolio and associated information repositories serving the Global Regulatory Affairs organization and business processes. This role will partner with business stakeholders as well as liaise with Takeda Digital to ensure activities are implemented to plans with Information integrity and according to defined requirements and timelines.
You will also be accountable to curate Regulatory information to ensure the highest quality to meet Health Authority standards and Takeda's strategic needs. Oversees and ensures appropriate resourcing of global information management projects; litigation support; M&A; divestitures, etc.
As part of the GRO Regulatory Information Management team, you will report to the Head, Regulatory Information Management and Digital Innovation.
How you will contribute:
Responsible to deliver Regulatory Information Management (RIM) and associated processes and systems. Ensures information and data standards are aligned with Takeda's strategic business requirements (e.g. MDM, Regulatory strategy, Industry standards, HA expectations)
Identifies opportunities for regulatory automation solutions and may build out business cases for the evaluation and build of solutions.
Ensures appropriate enterprise information and solution integration points for consistent and compliant data flow.
Partners closely with Digital to ensure fully integrated regulatory systems, experience, and information model and externally facing capabilities.
Ensures there is a strategy and implementation plan for seamless integration of information and content up and downstream as well as across the governed regulatory systems portfolio.
Lead and maintain a collaborative program of continuous improvement within the regulatory solutions organization.
Demonstrates a high level of leadership and expert understanding of global RA information/data set regulations and guidelines by applying interpersonal skills and expert RA knowledge to address and overcome challenges that arise
Successfully communicates and negotiates with international Health Authorities as necessary, directly or indirectly
Contributes to day-to-day GRA RIM initiatives (integration, acquisitions/divestitures, IDMP,xEVMPD, SPOR, MDM).
Collaborates with other IM leaders to deliver value-add business-facing services to improve system user experience, information accuracy, and timeliness
Engage and lead with external regulatory forums and consortia on innovation related to solutions and information for the needs of Global Regulatory Affairs
Ensures Takeda portfolio support with appropriate SLAs and customer focus
Lead and define the development and execution of strategic and change management initiatives.
Oversees outsourcing activities performed by the external vendor(s) for the management of regulatory information including the development and oversight of robust KPIs and the oversight of vendor activities for RIM system maintenance.
Minimum Requirements/Qualifications:
Bachelor's degree or related experience is required. Scientific or closely related field preferred.
At least 8 years of experience in Pharmaceutical industry, with more than 5 years in Regulatory Affairs, research and development, quality assurance/compliance.
Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.
Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and industry forums, international experience preferred.
Expert understanding of scientific principles and regulatory information standards/requirements relevant to global drug development and post-market support.
Understanding in regulatory publishing and Information management tools is required.
Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
Exercises good judgement in elevating and communicating actual or potential issues to line management.
Active participation in Agency/Industry groups/forums expected. Recognized as an expert in the field.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Flexible Work Paths
Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Base Salary Range: $ 130,200 - $186,000, 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.
This position is currently classified as "Hybrid" or "remote" in accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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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
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