Artwork Lead Large Molecule and Cell and Gene Therapy

Job Description

Vertex is seeking a Senior Manager to serve as the Artwork Lead for Large Molecule and Cell and Gene Therapy. This role will be an emerging leader within Manufacturing Sciences and Technology (MS&T) and lead the artwork technical area of Large Molecule & Cell and Gene Therapy - two new and exciting areas of work for Vertex. The Sr. Manager, Artwork Lead delivers on complex project activities and is responsible for ensuring positive and effective relationships with all stakeholders. This role will serve as a key participant on internal and external cross-functional teams within this assigned technical area. This position will contribute to Vertex's artwork development and commercial processes (i.e. - Instructions for Use, cell and gene therapy expansion), new product launches, lifecycle artwork updates and implementation into market. The candidate will be a leader, with broad awareness of best global practices within pharmaceutical artwork development. Strong professionalism and communication skills are critical. This is a remote position.

Key Responsibilities

• Create and evolve the Instructions for Use process within Artwork in alignment with the Regulatory and Human Factors processes.
• Drive and document implementation practices and metrics related to Instructions for Use and new modalities in the defined technical area
• Independently leads Artwork in the area of Large Molecule/Cell and Gene Therapy by driving cross-functional collaboration and alignment of the strategy and artwork for the Information For Use (IFU) and key artwork documents.
• Assists in the development of artwork and artwork processes to ensuring cross- functional alignment for other medium and/or high complexity products (including combination, Software as a Medical Device, and standalone medical device products).
• Manages the process for alignment of local labeling with IFU for assigned products, including assessment of changes needed
• Managing artwork development activities (brief approval, artwork preparation, and proofreading, etc.) for new products and updates to current product artwork with minimal supervision
• Compile requirements from internal stakeholders and manage day to day activities of external graphics providers and printers to meet manufacturing and project timelines.
• Support the creation and review of SOPs and training materials
• Support training global internal and external users in the artwork process and management system
• Ability to manage multiple high-priority projects concurrently
• Takes full responsibility within scope of the position to work with various stakeholders (such as Quality, Supply Chain, Tech Ops, Regulatory, Graphics agency, etc.) to proactively and collaboratively resolve issues that may negatively impact project timelines or deliverables
• Independently investigate and complete deviations as applicable

Education and Experience:

• Bachelor's degree in related discipline
• 6 years of relevant experience within the pharmaceutical industry in a similar role including relevant artwork, IFU, regulatory, technical writing or ISO standard experience.

Required Qualifications:

• Experience working in a GMP environment
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment
• Experience and knowledge of ISO standards related to IFUs
• Previous experience with Instructions for Use
• Strong initiative and ability to identify issues and develop solutions
• Ability to use Microsoft Office Suite programs (Excel, PowerPoint, Visio, Word)
• Strong interpersonal and relationship skills
• Experience with an Artwork Management System
  

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com