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2023 Summer Internship - Global Regulatory Affairs QMS Compliance at Takeda Development Center Americas, Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Boston, Massachusetts





Job Description:

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's Privacy Notice and 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

About the role:

At Takeda, we are committed to lifelong learning.

To that end, Takeda's summer internship program blends real world experience with an extensive overview of the pharmaceutical industry. Knowledgeable mentors will provide guidance as you gain professional hands-on experience to start your career or further develop in your expertise.

The summer internship program is a full-time commitment of 12 weeks in length and offers a unique perspective into a world-class pharmaceutical company. Our internship program also provides you the opportunity to network with people at Takeda through various planned events and activities.

Project Outline:

GRA QMS Compliance

Change Control Assessments - Global and Local Change Control Compliance Measurements

The objective of the project is to support Change Control assessments globally and locally to create consistent and controlled nomenclature, information gathering, and documentation practices within Trackwise. The outcome of this is to improve overall system compliance, timeliness and measurement for Change Control activities. This will provide an opportunity for logical metrics measuring, with a focus towards governance and areas in need of support. The overall project will help drive greater oversight of compliance and conformance to the global Takeda Change Control process. Steps will include:


  • Identification and recommendation for Track Wise Fields to be completed

  • Development of sample language to be used to aid in filtering and consistency

  • Determination of required vs optional for consistency

  • Analysis and reporting of results

This position will be Onsite (Hybrid considerations to align with department schedule)

How you will contribute:


  • Deadline-driven with a high level of organizational and planning skills

  • Strong analytical, problem-solving, and oral and written communication skills

  • Ability to work well in teams, effectively manage projects, and present ideas clearly and concisely.

  • Global mindset to grow in a diverse work environment

  • Excellent communication and leadership skills

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

  • Some understanding of industry landscape and obligations to Health Authorities

Requirements / Qualifications:

As stated above, Takeda is committed to lifelong learning opportunities. To that end, our internship program is open to currently enrolled students seeking early experiences and non-traditional candidates interested in making a career change and gaining new experience.

The requirements for these two groups of candidates are specified below:

Candidates currently enrolled at an accredited university:


  • Must be authorized to work in the US without sponsorship (i.e., Takeda will not sponsor interns)

  • Must be available to work full-time (40 hours/week), within core business hours (8 AM-5 PM), for a minimum of 12 weeks during the summer months

  • Minimum GPA 3.0/4.0

  • Undergraduate, Graduate, PhD, MD student with at least one year of university studies before internship

  • Return to university for at least one semester post-internship

  • Takeda does not provide student housing or housing stipends

Non-traditional candidates not currently enrolled at university:


  • Must be authorized to work in the US without sponsorship (i.e., Takeda will not sponsor interns)

  • Must be available to work full-time (40 hours/week), within core business hours (8 AM-5 PM), for a minimum of 12 weeks during the summer months

  • Must provide a cover letter explaining why you are seeking this internship, relevant experience that makes you a good candidate, and what you hope to achieve through the experience
    • Strong preference for non-traditional candidates with some experience relevant to the desired intern role


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





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