Associate Director, Medical Writing and Clinical Communications

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 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.

The Associate Director, Medical Writing and Clinical Communications will 1) collaborate with project teams on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs); 2) manage external and internal communications regarding key clinical development activities.

Responsibilities

• Assure efficient completion of high quality and on-time writing deliverables through effective planning and management of medical writing resources. When necessary, write or QC documents or lead document review meetings, to deliver high-quality documents on-time.
• Work with project management and team members to develop and align on document writing timelines and review cycles. and
• Assure that writing projects are adequately staffed. Manage contract and employee medical writing resources, assuring on time delivery of high quality written documents. Facilitate efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors.
• If/when needed, plan, write, edit, and format key documents with minimal supervision, including clinical protocols, investigator brochures, clinical study reports, pharmacy and other manuals, integrated safety and efficacy summaries and related documents. Other documents may include informed consent forms, health authority briefing books, and scientific publications.
• Represent Medical Writing on project teams.
• Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders.
• Serve as subject matter expert for clinical documents and their production.
• Lead SOP and template development and maintenance for medical writing documents.
• Manage external and internal communications regarding key clinical development activities, including important safety events, changes to development programs, etc that require broad internal and external communications. Assure an agreed communication plan is in place and that plan is executed upon in a timely way.

Qualifications

• Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree (M.S./Ph.D.) and/or professional certification/credentials strongly preferred.
• 4+ years of experience as a medical writer in the sponsor and/or CRO setting for applicants with a Masters or higher degree. 7+ years of experience as a medical writer in the sponsor and/or CRO setting for applicants with a Bachelors degree. Experience with regulatory submissions (CTA/IND/NDA/BLA) required. Knowledge of eCTD formatting is a plus.
• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
• Successful track record of managing people and multiple projects in a fast-paced and deadline-driven environment.
• Impeccable attention to detail and ability to assure completion or 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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