Job Details

Requisition Number 17-0059
Post Date 8/27/2017
Company Akcea
Title Consulting Director, Medical Information
Employment Type Temporary
Description

 

Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics.

Established as a subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics. In July 2017, Akcea closed its initial public offering of common stock and is listed on the NASDAQ Global Select Market under the symbol “AKCA.”

Consulting Director, Global Medical Information

Akcea has an opening for a Director of Global and Medical Information. This is a temporary position, with an anticipated duration of six to nine months. As a key member of the Medical Affairs team the Consulting Director of Global Medical Affairs will leverage therapeutic and product knowledge to launch and oversee a global medical information department.

He/she will provide direct guidance and strategic vision in the launch of a global medical information including development of standard response letters, internal and external processes, training, and reporting. 


Duties & Responsibilities:

•     Launch a Global Medical Information department

  • Oversee Medical Information including vendor management, review of monthly reports of Medical Information Request Form reports, resource allocation and budget management.
  • Provide/coordinate clinical, product and process training to external contact center staff, internal stake holders to assure compliance with guidelines and quality delivery of medical information.
  •  Develop and update standard response documents, including standard response letters and “frequently asked questions” (FAQ) documents by collaborating with internal/external writers, always assuring quality data and scientific rigor.
  • Respond as guidelines dictate to draft, have approved, and train to standard response letters to address inquiries with no approved SRL. 
  • Review new and relevant data so that medical information content is updated proactively and communicated with external vendor delivering medical information services.
  • Submit and represent all standard response letters to the medical materials review committee.  Assuring the highest quality of review of all materials.
  • Willingness to travel occasionally, up to 15% of role.  Travel may include international.

Basic Qualifications:

  •  PharmD, PhD  or other terminal degree required
  • A minimum of 2 years’ professional experience in Medical Information
  • Demonstrated strong verbal, written, and presentation skills.

Excellent salary and benefits package offered.

For more information on Akcea and to apply for this position, please visit our website, www.akceatx.com

Reference Requisition #17-0059

 

NO PHONE CALLS PLEASE.PRINCIPALS ONLY.

 

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