Pre-clinical Technical Writer and Documentation Specialist

Location
San Diego, CA, US
Posted
Sep 17, 2020
Ref
5555
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
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.

The Pre-clinical Technical Writer and Documentation Specialist provides editorial support of technical and regulatory documents and manages document reviews. This role is the subject matter expert and super-user in the management and use of Novartis preclinical and regulatory document management systems.

Responsibilities
  • Working closely with the scientific Subject Matter Expert (SME), manage technical and regulatory writing templates, guidelines, and instructions.
  • Provides editorial support, ensuring quality of all scientific content, with a focus on clarity, accuracy, and consistency, while maintaining adherence to proper format, regulatory requirements, and company guidelines/styles/drafting processes.
  • Initiates and manages multiple rounds of document review and ensuing revisions, interacting positively and professionally with all levels of reviewers from SME to senior management, effectively resolving conflicts and building consensus, as necessary.
  • Simultaneously manages multiple overlapping projects at different stages and on separate development programs and contributes to overall process improvement.
  • Responsible for document management and converting nonclinical scientific data into clear, scientifically sound, well-structured scientific, technical and regulatory documents intended for global health authorities and internal/external stakeholders.
  • Edits 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.
  • Liaison between authors and project teams, Clinical Development, Novartis submissions management, regulatory affairs, or other key partners or stakeholders for nonclinical technical reports and regulatory submission documents.
  • Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced.
  • Become the subject matter expert and super-user for Novartis GTx in the management and use of Novartis preclinical and regulatory document management systems and their use by Novartis GTx.
  • Responsible for archive activities for various regulatory documents.
  • Coordinates with documentation management in SharePoint, document change tracking in electronic systems and other RA systems (may also include the clinical documentation system).
  • Participate in the writing and reviewing of Regulatory SOPs, Work Instructions, and internal guidelines.

Qualifications
  • BA/BS within a scientific discipline and/or technical editing and writing.
  • Minimum 5 years industry experience with a minimum of 4 years of clinical and regulatory writing experience within the pharma/biotech industry.
  • Demonstrated experience and a clear understanding of regulatory document submission content and format requirements.
  • Experience and understanding of controlled document management systems and regulatory compliance requirements.
  • The ability to multitask, prioritize, and work under pressure in adhering to deadlines.
  • Good project management and organizational skills.
  • Proficient in preparing accurate, written reports.
  • Strong attention to detail, establishing priorities and scheduling.
  • Excellent interpersonal and communication (verbal and written) skills.
  • Ability to work independently, take initiative and complete tasks to meet deadlines.
  • Computer proficiency (Word, Excel, Prism, Adobe and related software) and fluency in the English language is required.
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Well-developed analytical skills and strong knowledge of technical terminology.


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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