Takeda

Lead, Data Scientist Regulatory Intelligence and P...

Job description

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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 to bring life-changing therapies to patients worldwide.

Join Takeda as Lead, Data Scientist Regulatory Intelligence and Policy Research where you will lead and support intelligence and research work using a data-driven approach. You will also participate and support in the global coordination of various regulatory activities including Takeda SME representation on external workstreams and trade groups, coordination of Takeda’s consultation document review and commenting process, etc.

How you will contribute
  • Serve as Global Regulatory Intelligence contact for key stakeholders including therapeutic areas and regional teams as determined in collaboration with regional EU, US, Japanese, and Growth & Emerging Market Regulatory Intelligence colleagues.
  • Dedicated data analyst and global lead for regulatory intelligence and policy to support regulatory research including case studies, data-driven policy support, regulatory data analysis, trend assessment, visualization, and interpretation, public dataset identification and characterization, and hypothesis testing. Work with Takeda colleagues to publish research when appropriate.
  • Support global coordination for Takeda subject matter expert participation on external workstreams and trade groups. Support global coordination of Takeda Guidance commenting and tracking, including region, country-specific, and ICH / multi-national guidances and regulations. Drive effective coordination and representation to ensure a Takeda one-voice policy.
  • Represent Global Regulatory Policy & Intelligence (GRPI) and Global Regulatory Affairs (GRA) on internal and external forums/networks as assigned. Provides impactful summaries and strategic advice, back to the business, regarding assigned internal/external activities.
  • Keep abreast of the latest data/information science, data tools, and other advanced analysis methods, and identify opportunities to use them to address needs in regulatory affairs
  • Conduct strategic assessments of external regulatory changes globally and work with subject matter experts within the Company, to support the decision-making process to understand and prioritize the regulatory risk & opportunities globally develop the strategies/positions and drive for appropriate action(s) relevant to Takeda’s Therapeutic Areas of focus and development projects.
  • Contribute to the development and execute the Regulatory Intelligence strategy. Keep abreast of internal and external changes, trends, development, and other dynamics relevant to the regulatory environment that may impact Takeda’s regulatory and/or access strategies and disseminate information.
  • Contribute to and lead the development and implementation of appropriate regulatory intelligence management systems, processes, and standards within GRPI, GRA, and across Takeda as assigned, including vendor management and internal change control.
  • Work closely and partner with GRPI colleagues and Subject Matter Experts to plan and execute regulatory advocacy positions, strategies, and tactics and facilitate engagement on key topics of interest.
  • Support metrics development and maintain consistent oversight of deliverables across GRPI. Keep all internal customers, partners, and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level.
  • Responsible for demonstrating Takeda Leadership Behaviours.
Minimum Requirements/Qualifications
  • BSc, Advanced scientific-related degree preferred.
  • A minimum of 5 years of experience in the pharmaceutical industry in regulatory intelligence, regulatory policy, or regulatory affairs.
  • Degree in computer science, mathematics, data analytics, statistics, informatics, economics, or similar concentration required, plus minimum 3 years of working experience in this area.
  • Solid understanding of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU with a good understanding of basic regulatory requirements and emerging markets. Sound knowledge of intelligence tools and methods.
  • Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy, and strategy for the region.
  • Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity, and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Proven success at stakeholder engagement across organizational levels and boundaries.
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 a 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 $137,200 to $196,000, based on the candidate's 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 remote in accordance with Takeda's Hybrid and Remote Work policy.

$137,200 to $$196,000 based on the candidate's 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.

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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