Principal Medical Writer

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

Prinicpal Medical Writer will lead teams through document development process, communicating timelines and standards to the team.

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.

Novartis Gene Therapies 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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