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Associate Director Global Oncology Medical Information & Review

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
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  • Versatile
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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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Associate Director Global Oncology Medical Information & Review

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Job ID R0014691 Date posted 12/24/2019 Location Cambridge, Massachusetts

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Job Description

The Associate Director Medical Information and Review, will serve as a functional expert in the area of Medical Information and Review for their assigned products/ Therapeutic Areas and ensure alignment, integration, for process and technology efficiencies in medical information activities across therapeutic areas for Global Medical Affairs Oncology (GMAO).

The candidate in this position will be required to partner with the Head of Medical information and Review on the implementation of global processes, systems and vendors. The primary focus will be to oversee, plan and deliver high-quality, balanced and timely medical and scientific information deliverables for assigned products upon request from internal and external business partners, health care professionals (HCPs) and consumers. They must provide advanced medical information / clinical expertise for assigned products to internal stakeholders (eg, medical affairs strategy teams, product teams within R&D, commercial Brand teams) and external stakeholders (eg, HCPs, patients and advocacy groups).

In addition they must excel in providing advanced medical and scientific review of medical affairs materials and, if required, promotional materials to support the medical and promotional review processes.

Lastly it may be required support Medical Information and Review needs and activities for other brands and pipeline products, as well as above brand activities to ensure a best in class medical Information and review function, ensuring Takeda Oncology’s professional standing and integrity with patients, healthcare professionals and the pharmaceutical industry through high-quality and aligned medical information and communication.

ACCOUNTABILITIES

  • Utilizing advanced medical information /clinical expertise, independently oversee, plan, develop, maintain and provide high-quality, balanced and timely medical and scientific information deliverables including Standard and Custom Response Letters, Global Core Response Documents, Clinical Dossiers, and FAQs, to both internal and external customers.
  • Work cross-functionally with Global Medical Affairs Oncology, Quality Assurance, Safety, Clinical Research and Development to ensure alignment and accuracy of Medical Information.
  • Provide guidance and direction to the Medical Information Contact Center staff on handling routine and complex cases; monitor and manage complex escalated cases from the Medical Information Contact Center.
  • Partner with the Head of Medical information and Review on the implementation of a global Medical Information system for oncology, in collaboration with other Takeda business units, as appropriate.
  • Co lead the global integration and optimization of Medical Information resources, activities, document delivery, and relevant cross-functional databases, including a Medical Information response repository, to support regional and local personnel.
  • Develop and deliver ongoing Medical Information training for internal groups, Contact Center personnel, medical affairs teams and sales groups to ensure compliance with Medical Information policies and procedures.
  • Provide advanced medical and scientific review of medical affairs materials and, if required, promotional materials to support the medical and promotional review processes, as well as providing project management support for the medical review process, as needed.
  • Conduct strategic assessment (gap analysis) of medical information needs within therapeutic areas and develop fulfillment strategies. As a result they develop global core response documents (GCRDs) that are strategically aligned with regional and local needs, and partner with global Medical Leads, as appropriate, to ensure approval of GCRDs.
  • Serve as the Medical Information and Review subject matter expert on the Global Medical Strategy Team Oncology (GMSTO) meetings for the relevant products/ therapeutic areas.
  • Inform medical strategies by disseminating actionable medical insights and trends on a consistent basis.
  • Co-lead the development and maintenance of departmental procedural guidelines and SOPs.
  • Provide advanced support to product booths at professional scientific meetings and congresses as appropriate. Participate in booth design and congress activities as required.
  • Coach and mentor interns, fellows, students and Medical Information & Review team members.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education and Experience:

Required:

Advanced scientific degree (PhD, PharmD or equivalent) 4 + years Medical Affairs experience or related industry experience Excellent written and oral communication skills Oncology experience strongly preferred

Preferred Training/Experience:

  • Demonstrated results in one or more medical information and review groups
  • Understanding of pharmaceutical clinical development and product life-cycle management.
  • Cross-functional team participation within the Pharmaceutical or related industry.

Global Core Competencies

  • Creativity and innovation: Proven ability to think outside the box and challenge status quo is mandatory.
  • Strategic Approach: Ability to adjust to  changes in the business landscape due to increasing understanding and ongoing assessment of the environment.
  • Engage Others: Ability to participate on teams effectively with a focus on delivering results
  • Collaboration: Ability to cultivate a broad network of relationships throughout the organization
  • Lead Change: Ability to adjust to changes in functional or cross-functional plans and priorities in response to changes in strategic direction
  • Drive for Results: : Execute on strategies and goals that are closely aligned with company objectives, and deliver on metrics that track and assess performance.

Pharmaceutical Industry Acumen: Strong understanding of regulatory and compliance environment

ADDITIONAL INFORMATION

  • Ability to drive to or fly to various meetings or client sites, including overnight trip. Ability to drive to or fly to various meetings or client sites, including overnight trips. Requires approximately 10-20% travel

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0014691

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