Posted to MedZilla on 1/20/2018


Takeda Pharmaceuticals

US-MA, Research investigator, Non-Clinical Safety 1703192-MZ


 
 

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Study Monitor in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Study Monitor working on the Global Drug Safety Research and Evaluation team, you will be empowered to coordinate Regulated (GLP) and Non- GLP nonclinical development studies at Contract Research Organizations and perform and document CRO site visits to monitor study performance, and a typical day will include:


POSITION OBJECTIVES:

  • Coordinate Regulated (GLP) and Non- GLP nonclinical development studies at Contract Research Organizations (CROs)
  • Review study-related documents (protocols, amendments) for completeness, accuracy and consistency
  • Perform and document CRO site visits to monitor study performance
  • Coordinate activities collaborating with multiple departments (Pharmaceutical Sciences, DMPK, and QA, etc.) across Global- Takeda
POSITION ACCOUNTABILITIES:
  • Coordinate protocol review and dose selection meetings
  • Schedule, track, and monitor study progress
  • Schedule milestones of study activities such as peer reviews as well as corresponding reports from internal and external laboratories
  • Track reporting deliverables and graph real-time data
  • Maintain study correspondence for assigned studies
  • Ensure finalization of study reports to support regulatory submissions

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Candidate should be a self-starter, and able to work with minimal supervision to achieve objectives in a timely manner
  • Good working knowledge of FDA Good Laboratory Practice (GLP) Regulations as set forth in 21 CFR Part 58, OECD and ICH guidelines
  • Experience with the design and conduct of regulated nonclinical studies
  • Strong interpersonal and organizational skills
  • Experience in reviewing study data and reports
  • Excellent communication skills and is able to effectively communicate both internally and externally in performing role as liaison between Takeda and CRO
  • Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems
  • Minimum of BS, in a scientific discipline and/or 5+ years of industry experience, working at a pharmaceutical company and/or CRO

LICENSES/CERTIFICATIONS:

  • AALAS certification desirable

PHYSICAL DEMANDS:

  • Routine demands of an office based environment

TRAVEL REQUIREMENTS:

  • Ability to travel domestically and internationally, 75%

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

Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

#LI-JT1


Schedule

Please visit our website at takedajobs.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.