• Principal Medical Writer

    Job Locations US-IL-Bannockburn
    Posted Date 2 weeks ago(12/3/2018 9:55 AM)
    Job ID
    2018-2768
    # of Openings
    1
    Category
    Medical Affairs
  • 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, 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.

    Responsibilities

    • Communicate timelines, documents needed and process standards to team.
    • Interpret and explain data from a variety of sources.
    • Complying with internal and external processes, SOPs, and appropriate guidelines.
    • Lead and manage a cross-functional team through the document development process related to authoring and reviewing of clinical documents.
    • Authoring regulatory documents, including but not limited to: clinical study reports (CSRs), pre-IND Briefing book/package, advisory committee briefing document), Investigator Brochure(s), DSURs, other regulatory documents including briefing documents for health authorities, responses to questions, etc.
    • Lead the preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging and style.
    • Leading the writing review process and resolving issues, errors, or inconsistencies with pertinent team members to ensure timely completion and quality of assigned documents.
    • Coordinate with other clinical program medical writers and other medical writers as needed to maintain consistency across documents within a project and across indications.
    • Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) compliant presentation.
    • Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced.
    • Mentor, coach and/or otherwise assist in the training and development of (Senior) Medical Writers.
    • Submission-level experience (e.g., Clinical Summaries [including Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), Clinical Overview, Clinical Summary, PK/PD summary]) preferred.

    Qualifications

    • BA/BS within a scientific discipline, advanced degree (e.g., PhD, MD) strongly preferred.
    • 4+ years of clinical and regulatory writing experience within the pharma/biotech industry.
    • Good familiarity with Regulatory Agency guidelines.
    • Prior CSR and Summary Document generation experience, preferably at a sponsor.
    • Prior experience with submissions in Common Technical Document (CTD) format.
    • Knowledge of eTechnology related to regulatory submissions activities (eCTD, EDMS, Life Cycle Management).
    • Ability to exercise independent judgement in developing methods, techniques and evaluation criteria for obtaining results.
    • Detailed and experience-based understanding of applicable regulations and guidelines (e.g. Code of Federal Regulations [CFR], European Directive and International Conference on Harmonisation [ICH]).
    • Strong computer skills: proficiency in MS Word.
    • Ability to work without close supervision.
    • Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
    • Ability to work well within an international team.
    • Must be detail-orientated, thorough and methodical.
    • Exceptional written and verbal communication skills.

     

    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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed