Manager, Quality Control Medical Writing

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

Responsible for managing the conduction of quality reviews and formatting for all documents produced by the AveXis Medical Writing Team. In addition, this position is responsible for performing quality reviews, copyediting clinical documents, regulatory submissions, medical/scientific publications, and other Medical Writing documents.

Responsibilities

• Coordinates review and editorial functions for Medical Writing documents and projects. Manages external contract/CRO QC resources as needed.
• Performs detailed quality control review checks of clinical and regulatory documents, data listings, and any submission documents.
• Copyedits, proofreads, or substantively content-edits documents, including grammar, spelling, style, and layout.
• Ensures that document content is consistent with internal and ICH guidelines.
• Assists with development of document formats and templates.
• Assists Medical Writer or other team members with responses to quality-related document questions and comment consolidation.
• Assists with literature searches, reference management, and creating / checking bibliographies.
• Assists with project team coordination and project timelines, as needed.
• Provides input regarding project budgets and resources and assists with budget monitoring as requested.
• Assists with the training, mentoring, and supervision of Medical Writing team members.

Qualifications

• Bachelor's degree or higher.
• 5-7 years of experience working on clinical documents.
• 3-5 years of experience in electronic submissions.
• Minimum 1 year of experience in project management or in a team-lead role.
• Understanding of submission components, timing, and assembly.
• Knowledge of publishing software and tools used throughout the industry, including MS Office, Adobe Acrobat, ISIToolBox, InSight Publisher, and related programs.
• Ability to write and edit appendix cover language and corresponding link text.
• ELS, AMWA writer's certification, regulatory certifications preferred.
• Proficient in use of Microsoft Office and project management software systems.
• Desire and ability to work in a fast-paced, dynamic start-up environment.

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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