Posted to MedZilla on 6/19/2019


Takeda Pharmaceuticals

US-MA, Medical Information & Review Manager R0009523-MZ


 
 

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Job Description

Objective:

The purpose of this position is to: 1) deliver high-quality, balanced and timely medical and scientific information for assigned oncology product(s) upon request from internal and external business partners, health care professionals (HCPs) and consumers; 2) manage medical information activities for assigned oncology product(s) including developing standard and custom written and verbal responses, Clinical Dossiers, Global Core Response Documents, Letters and Frequently Asked Questions (FAQs); 3) provide medical information / clinical expertise for assigned product(s) 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); 4) provide medical and scientific review of medical affairs materials (and, if required, promotional materials) to support the medical (and promotional) review process, as well as providing logistics and project management support for the medical review process, as needed.

Accountabilities:

  • Develop, maintain, and provide high-quality, balanced, and timely medical and scientific information, 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 of routine cases; monitor and manage complex escalated cases from the Medical Information Contact Center.
  • Coordinate with Global Medical Affairs Oncology colleagues and vendors to oversee and develop medical information content, as/if appropriate
  • 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 medical and scientific review of medical affairs materials (and, if required, promotional materials) to support the medical (and promotional) review process, as well as providing logistics and project management support for the medical review process, as needed.
  • Serve as the Medical Information and Review representative on the Global Medical Strategy Team Oncology (GMSTO) meetings.
  • Create, maintain and communicate metrics and performance to Senior Leadership.
  • Assist in the development of departmental procedural guidelines and SOPs.
  • Support product booths at professional scientific meetings, as needed.
  • Assist with mentoring interns and students, as required.

Education, Experience and Skills:

Required:

  • The qualified candidate will have a doctoral degree in a health sciences related field such as a PharmD, MD or Ph.D., with a thorough grasp of the pharmaceutical industry.
  • 2+ years of healthcare or related experience (managed markets, clinical practice, research or academic).
  • Excellent communication skills, both oral and written, and able to engender trust and respect of peers, subordinates and superiors.
  • Well-versed in highly technical and scientific languages to communicate with HCPs, KOLs, Medical Affairs, Research and Development, as well as other key internal and external stakeholders.
  • Firm understanding of the drug development process including key phases, processes, and techniques utilized for both pre- and post-marketing research studies.
  • Proven track record of teamwork, leadership, timely decision making and results orientation in meeting objectives.
  • Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.


Desired:

  • Therapeutic area experience.
  • Clinical, research, or teaching experience.
  • Board Certification in therapeutic area of interest.
  • Completion of pharmaceutical industry related residency or fellowship.

Travel Requirements:

  • Ability to drive to or fly to various meetings/client sites.
  • Overnight travel (up to 10-20%), which may include some weekend commitments.
  • Travel may vary depending on therapeutic responsibilities.

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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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