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Manager, GMA Evidence Generation Operations (Global External Research) 60030534

Cambridge, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

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

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

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

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

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

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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Manager, GMA Evidence Generation Operations (Global External Research) 60030534

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Job ID R0011352 Date posted 08/29/2019 Location Cambridge, Massachusetts

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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 Manager, GMA (Global Medical Affairs) Evidence Generation Operations

team in our Cambridge, MA 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 Future to people around the world.

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

OBJECTIVES/PURPOSE:

  • Manage all aspects of assigned program including Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR), and Externally Sponsored Collaborative Clinical Research (CCR) studies for assigned therapeutic areas and product programs.
  • Manage TA and product level study budgets and communicate study activities to internal stakeholders.
  • Oversee and manage the activities of EGO project managers, including the initiation, tracking, completion, and reporting of studies.
  • Responsible for the conduct of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as external regional and country specific regulatory guidelines.
  • May serve as the therapeutic operational area lead for interfacing with internal stakeholders (e.g. GMA, Region and LOC medical leads, TA Medical Heads, alliance partners, etc.) and external investigators to develop and execute research plans and budgets.  

  • Oversee and/or facilitate receipt, processing, and internal cross-functional review of internal/external study submissions 
  • Review and approve research committee materials including study concepts and protocols, meeting minutes, and investigator communications.
  • Lead required cross-functional review meetings to review, approve, and track studies and ensure proper documentation and archiving (minutes, team communications, etc.) of review outcomes.
  • Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information).
  • Oversee and/or facilitate the management of the internal EGO VisionTracker (or equivalent system) and document repositories per Medical Affairs SOPs and processes.
  • Coordinate with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies.
  • Contribute to pre- fair market value (FMV) evaluation of proposed study budget and oversee the conduct of FMV assessments of budgets submitted for approved studies in accordance with Takeda policies and procedures

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Entry level understanding of research and the pharmaceutical industry

Basic knowledge of systems

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Required:

  • Bachelor’s degree required, preferably in a health sciences related field with 3 years of research related experience and/or pharmaceutical industry experience.
  • Proven track record of strong leadership, project management and demonstrated ability to coach and mentor individuals.
  • Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of clients both internal and external to Takeda.

Desired:

  • Experience overseeing work of and mentoring other individuals with a variety of scientific and non-scientific backgrounds and training
  • Research experience (health sciences related), Pharmaceutical Industry including CRO
  • Experience working in a global organization highly desirable.

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-TL1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0011352

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