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Global Regulatory Affairs Compliance Internship - Summer 2024

Boston, Massachusetts
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  • Job Type: Full Time
  • Job Level: Senior
  • Travel: Minimal (if any)

Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.

At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.

Job ID R0112139 Date posted 12/05/2023 Location Boston, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

At Takeda, we strive to create an exceptional people experience for patients, communities, partners, and employees. As a patient-focused, values-based, R&D-driven global biopharmaceutical company, we know our decisions and actions affect people’s lives. We look to our values of Takeda-ism, which incorporates Integrity, Fairness, Honesty and Perseverance, and Patient-Trust-Reputation-Business as a guide in our decision-making process to ensure we do what’s right – for our patients, our people and society.

Are you ready to embark on a transformative journey with Takeda? Our paid 10–12-week summer internship program is designed to immerse you in a dynamic learning environment, featuring a blend of developmental and social activities.

As a Takeda intern, you'll have the opportunity to contribute to impactful projects that play a crucial role in shaping both our business and the well-being of patients. This experience will not only allow you to apply your technical and business knowledge but also empower you to showcase your analytical strength and creative problem-solving skills.

Seize this chance to gain hands-on experience, expand your skill set, and make a meaningful impact on the healthcare industry. We invite you to be a part of our innovative and collaborative team, where your contributions matter.

For more information about Takeda, please visit www.takeda.com. op of Form

Please note that Takeda does not provide intern housing or a housing stipend.

Project Outline:

GRA Global Compliance

Collaborate in creating process templates that detail GRA processes and steps followed on day-to-day work, but not necessarily covered in in controlled documents (SOPs, TOOLs).

The objective of the project is to capture useful information in the same and easily accessible format for each process and share with the wider GRA team as needed.  

Activities can include:

  • Regulatory Activities in The Management of Clinical Trials

  • Audits/Inspections preparation activities

  • Business Partner audits and Questionnaires

  • Investigation of deviations

This position will be hybrid (remote and onsite to support the departments schedule)

How you will contribute:

  • Exceptional interpersonal, verbal communication and writing skills.

  • Deadline-driven with an elevated level of organizational and planning skills.

  • Strong quantitative, analytical, problem solving and conceptual skills.

  • Proven record of accomplishment of teamwork, adaptability, innovation, initiative, and integrity.

  • Global mindset to grow in a diverse work environment. 

  • Proficiency with Microsoft applications (Excel, Word, PowerPoint; Outlook)

  • Knowledge of relevant systems and software used in the pharma/biotech industry (document management systems, business process workflow systems, tracking tools)

  • Some understanding of industry landscape and obligations to Health Authorities

Requirements / Qualifications:

  • Currently authorized to work in the United States without sponsorship. Takeda does not provide sponsorship for internship positions.

  • Available to work full-time (40 hours per week), within the core business hours of 8:00am – 5:00pm, for 10-12 weeks during the summer months.

  • Undergraduate, Graduate, PhD, MD student with completion of a minimum of one year of university studies.

  • Must be enrolled in school the semester following your internship with Takeda.

  • Please note that Takeda does not provide intern housing or a housing stipend.

The hourly pay rate range is $20.00 per hour - $46.00 per hour. The final pay rate offered for this internship may consider several factors including, but not limited to, location, skills, education, and experience.

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Paid Intern (Fixed Term) (Trainee)

Time Type

Full time
Apply Now

Where you fit in

When you join our Regulatory Affairs team, you’ll help ensure the fastest, safest path for our treatments to get to patients. With colleagues who encourage you to question everything for better outcomes, you’ll be part of a team that’s deeply involved across each therapeutic area, from candidate selection to post-marketing.

At Takeda, you’ll join an environment with the energy and flexibility of a startup. We continue building on our 240-year history as a global biopharmaceutical leader through our innovative mindset and lean governance. Find everything you need on our Regulatory Affairs team to positively impact patients’ lives while taking strides within your own.

  • Oversee regulatory activities

  • Provide strategic focus

  • Collaborate cross functionally

  • Ensure regulatory compliance

We sit outside of the traditional disciplines, so we’re able to get involved in everything.Our role is to distill complex information and pull insights that give us a competitive advantage.

Nahid Latif - Head, Global Regulatory Affairs

Integrity is at the center of everything we do. This value is not something that you teach — it comes with the package.

Tatiana Ishida - Head of Global Regulatory Affairs, Marketed Products Group and Labeling

The heart of our work

Shining a light on new perspectives

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Exterior of Takeda Building

About our location

Boston, Massachusetts


View Map of Boston, Massachusetts

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