Senior Regulatory Writer

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Nov 27, 2018
Ref
2018-2745
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings 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 in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , 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.

AveXis is seeking a Senior Regulatory Writer to manage publishing activities, develop documentation and templates and manage archiving activities.

Responsibilities

  • Manage publishing activities (pre-publishing activities such as formatting documents) in partnership with team.
  • Liaison with medical writing in preparation, review and formatting of documents for regulatory submissions.
  • Prepare draft and final responses to agency inquiries; liaison with appropriate SMEs to circulate, edit and confirm accuracy and completeness.
  • Develop documentation for regulatory submissions (i.e INDs, BLAs, Pre-IND/BLA meeting requests, Briefing Books, other miscellaneous agency submissions/requests) with input from SMEs and others internally.
  • Be responsible for templates for regulatory documents.
  • Manage the process partnering with Program Management and Regulatory on timelines for delivery of regulatory documents for various projects.
  • Manage archive activities for various regulatory documents.
  • Coordinates with documentation management in SharePoint, document change tracking in electronic systems (i.e. for annual reports) and other RA systems (may also include the clinical documentation system).
  • Participate in the writing and reviewing of Regulatory SOPs, Work Instructions, and internal guidelines.
  • Ensure tracking and archiving of regulatory communications and submissions.


Qualifications

  • 5+ years of relevant industry experience in regulatory writing in the healthcare industry or academia or in a related area such as quality, regulatory, clinical research or product support/R&D.
  • High level content writing experience and experience.
  • Experience working with EDMS, regulatory publishing systems, and tracking databases.
  • Word documents/ISI proficiency is a must.
  • Familiarity with interpretation of applicable FDA, Canadian, EU and ICH guidelines related to clinical trial and marketing applications.
  • Demonstrated experience and a clear understanding of submission content and format requirements.
  • The ability to multitask, prioritize, and work under pressure in adhering to deadlines.
  • Strong oral and written communication and interpersonal skills.
  • Strong project management and organizational skills.
  • Ability to apply knowledge to new situations.


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.