Program Manager, Medical Affairs Operations

Job Locations US-IL-Bannockburn
Posted Date 4 weeks ago(1/24/2018 6:01 PM)
Job ID
2018-1106
# of Openings
1
Category
Medical Affairs

Overview

Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases?  AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101.  We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

 

AveXis, Inc. is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

 

The Program Manager, Medical Affairs Operations reports to the Associate Director of Global Medical Information and provides support for all aspects associated with the medical and promotional material review process, including operational support of Veeva database, managing and leading the medical materials review workflow, support for the promotional material review process, and provides Veeva support and training to Medical Affairs colleagues and vendors.

Responsibilities

  • Collaborates with cross-functional teams to ensure medical review process meets the needs of internal and external stakeholders
  • Assists in the execution of medical materials review plans, including support of medical communications and medical information materials
  • Independently determines and develops approaches to solutions, specifically in the medical review workflow
  • Provides operational support for Veeva database, including administrative responsibilities and training of Medical Affairs users and external vendor partners
  • Supports the implementation and optimization of the medical materials review process and promotional materials review process
  • Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.

Qualifications

  • BA/BS degree in biological sciences, marketing or business administration or a minimum of 4 years of related experience in a prior role
  • Minimum 4 years of US pharmaceutical product management
  • Ability to coordinate interdisciplinary teams (internal and external) to drive issues and projects to conclusion
  • Strong organizational, analytical and problem-solving skills essential
  • Excellent interpersonal and negotiation skills
  • Ability to prioritize tasks in a fast-paced environment.
  • Intermediate to advanced skills in Microsoft Office products such as Outlook, Word, Excel and Power Point.
  • Successful experience in fast-paced entrepreneurial environment;
  • Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
  • Maintains a positive and professional demeanor toward all customers and coworkers.
  • Adheres to all policies and procedures of AveXis.

 

The level of this position will be based on the final candidate’s qualifications.

 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

 

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

 

 

 

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