Posted to MedZilla on 10/13/2019


Takeda Pharmaceuticals

US-MA, Documentation Associate - Nonclinical Writing and Documentation R0012321-MZ


 
 

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Documentation Associate - Nonclinical Writing and Documentation in our Cambridge office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

OBJECTIVES:

  • Support global regulatory submission tasks
  • Assist with the management of both submission and non-submission supporting nonclinical documentation (reports, protocols, references, etc.) within the electronic document management systems (both regulatory and non-regulatory), and within the GLP hardcopy archive.

ACCOUNTABILITIES:

  • Assist with global regulatory submission tasks
    • Edit IND enabling study protocols for content, clarity, and consistency.
    • QC of submission documents back to supporting technical reports for accuracy.
    • Creation of nonclinical tabulated summaries for global regulatory submissions.
    • Creation of document plans for global regulatory submissions.
    • Other global regulatory submission tasks as needed.
  • Maintenance of study and report records in the Global study tracking system.
  • Management of documents within regulatory and non-regulatory EDMS.
  • Assist with assignment of nonclinical study and report numbers.
  • Management of ongoing system workflows.
  • Assist with management of hardcopy documentation within the Nonclinical Writing and Documentation archive.
  • Assist with hardcopy documentation requests.
  • Assist with obtaining literature references for use in regulatory filings.
  • Assist with business development-related tasks.
  • Creation of indices for partnerships, QC of documentation received or for transfer
  • Maintain compliance with applicable GLP regulations and SOPs.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • AS/BS (preferably in technology, sciences or information-related field) is required. A minimum 2 years-experience in a regulated environment with hands-on experience in document management, submission and/or large-volume document preparation. A team player with excellent communication skills and advanced computer literacy is required. Experience in biological research and development is preferred. Proven ability to work independently and effectively handle multiple projects. The successful candidate is required to have strong knowledge of word processing applications, database structure, multiple computer applications: electronic document management systems (Documentum or similar applications), EndNote, Oracle, SharePoint. Ability to work on several documents at the same time, high attention to detail and accuracy, ability to consistently hit deadlines, excellent written and oral communication skills. High level of competency required in teamwork for departmental and cross-functional project teams. Fundamental knowledge of worldwide regulatory submissions guidance a plus.

    TRAVEL REQUIREMENTS:

  • The position is located in our Cambridge, Massachusetts Office and minimal travel is required

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • 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

    Empowering Our People to Shine

    Discover more at takedajobs.com

    No Phone Calls or Recruiters Please.

    #LI-JT1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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