Associate Director, Publications

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 (ZOLGENSMA®). 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 an Associate Director Publications who will be a driver of publication strategy and dissemination of key scientific data. The successful candidate will play a major role in establishing AveXis' scientific expertise and communicating pre-clinical, clinical, and HEOR related data to the key stakeholders in the extended scientific/medical community.

Responsibilities

• Lead and execute all activities related to the preparation of scientific medical publications (i.e., medical, scientific, and health economics manuscripts, abstracts, posters, and oral presentations).
• Support the development and revision of the publication plan in conjunction with the project teams based on clinical development milestones, HEOR project deliverables, product life cycle, and scientific and unmet medical needs and gain endorsement of annual publication plan by key internal stakeholders prior to plan execution
• Support the timely execution of the publication plan, including vendor management.
• Ensure that scientific publication activities are within industry-standard guidelines for authorship and good publication practices (e.g. GPPE, ISMPP).
• Interface and effectively collaborate with external stakeholders and internal cross-functional teams including: clinical research, clinical operations regulatory, safety, biostatistics, to ensure accurate and timely completion/delivery of scientific publications.
• Coordinate the review, approval, and other applicable activities related to the development of scientific publication projects.
• Perform literature searches and interpret data, as needed, for drafting publication content.

Qualifications

• Advanced degree, (MD, PhD, or PharmD) with minimum of 5 years within bio-pharmaceutical industry required. Relevant professional certification/credential (i.e., CMPP, AMWA) is a plus.
• Proven strategic thinking and the ability to assimilate and interpret scientific content, and translate information for appropriate audience.
• Knowledgeable of US and international regulations, requirements, and guidance associated with scientific publications, including GPPE, ICMJE recommendations, and the development and documentation of compliant material with understanding of Datavision.
• Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
• Impeccable attention to detail and ability to complete writing assignments in a timely manner with minimal oversight.
• Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint.

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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