Associate, Clinical Operations Process Excellence

Location
Bannockburn, IL, US
Posted
Sep 17, 2020
Ref
5546
Hotbed
BioMidwest
Required Education
Associate 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 Associate, Clinical Operations Process Excellence, supports the implementation of process changes, training management and communications in addition to providing day-to-day departmental administrative, project and operational support to Clinical Operations Clinical Documentation and Process Excellence.

Responsibilities
  • Coordinates, reviews, and monitors entire suite of Clinical Operations procedures, guidelines, job aids, process maps, and training material throughout the document lifecycle, to ensure compliance with applicable ICH GCP requirements, CFR, FDA, EU, PMDA, GDRP and other regulatory guidelines/requirements and Novartis Gene Therapies policies.
  • Facilitates process related meetings with Stakeholders and Subject Matter Experts and ensure outstanding comments/actions have timely resolutions.
  • Maintains the master list of Clinical Operations SOPs, associated documents, training material and change history.
  • Edits documents for grammar, spelling, style and layout.
  • Performs quality control review checks and ensure document content is consistent with Novartis Gene Therapies procedures, ICH guidelines and other regulatory guidelines as applicable.
  • Drives the processing of quality documents in the controlled document management system.
  • Contributes to process training content in collaboration with cross-functional stakeholders/SMEs.
  • Assists in the compilation of reports and metrics.
  • Distributes department communications, documents and material as directed.
  • Supports department by assisting with tracking needs and administrative updates to document/tools.
  • Manages content and maintain department intranet/Sharepoint site with landing page for tools, templates, training material and folders.
  • May assist with Clinical Operations CAPA related activities.
  • Other related job duties as assigned.

Qualifications
  • Bachelor's Degree in Science, Communications, or English with 2 years relevant working experience.
  • Experience working in a clinical research/biotech/pharma company/CRO preferred.
  • Strong attention to detail.
  • Familiarity with MS Word, MS SharePoint, Adobe Acrobat Professional, MS Excel, MS Visio, and MS PowerPoint.
  • Knowledgeable in document control principles.
  • Experience in audit inspection, CAPA, and/or preferred.
  • Ability to work both independently and collaboratively.
  • Ability to multitask, prioritize, and work under pressure in adhering to deadlines.
  • Tolerance of ambiguity and willingness to work through complex issues
  • Strong work ethic, organizational/Project Management skills, oral and written communication skills, have a \u2018can do' approach, problem-solving skills, and be a team player.


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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