Job Description

Position Summary:

The Global Labeling Team at Vertex is seeking a highly motivated Manager of Labeling Compliance and Operations, who understands global labeling. They will ensure labeling compliance with regulatory requirements and global labeling processes. They will oversee and support the management of regional product labeling design, review, and approval in the European Union, United Kingdom and Switzerland, as well as approve packaging artwork, liaising with critical labeling stakeholders in commercial and technical operations.


They will have an ability to develop strong matrix working relationships and will be responsible for supporting the Global Labeling Leads (GLLs) in collaboration across the global regulatory affairs department and with cross-functional experts to develop global labeling strategies for marketed products. A pro-active individual, the Manager of Labeling Compliance and Operations will have an ability to lead, influence and work collaboratively.

Key Responsibilities:

Compliance: + Accountable for oversight of compliance with global labeling processes. This includes tracking of labeling updates and deviations and maintenance of controlled records.
Department Operations + Management of departmental projects to pursue process operations excellence (includes associated SOP and WI development and maintenance).
+ Support the development and maintenance of country regional text lists (cRTL).
+ Liaise with the Global Labeling team to ensure global translation activities are properly planned and forecasted and communicated to vendors and internal stakeholders.
Product Operations + Support GLL in the development and maintenance of regulatory labeling priorities and timelines for supported markets.
+ Author regulatory response documents for package component labeling responses.
+ Collaborate with commercial and other stakeholders in the creation and maintenance of artwork components for products.
+ Research regulations and precedent to support product package and labeling maintenance.
+ Design and facilitate or support Readability/Human Factors study programs, as needed.
+ Provide regulatory labeling impact assessments for change control records.
+ Collaborate with artwork and supply chain stakeholders to plan and implement label changes.
+ Responsible for internal communication of approved labeling to internal stakeholders and external posting of labels to Health Authority web sites, within defined timelines.
+ Manage packaging and labeling review and approval.
+ Proofreading and departmental QC, as needed.

This position will report to the Global Labeling Compliance and Operations Team Lead, GRA.

Skills/Experience:

Experience developing or maintaining package components, highly desired. Experience leading process improvement projects. Experience managing projects or coordinating multiple activities at once. Excellent planning, organizational, analytical, problem-solving, proofreading, and decision-making skills. Ability to lead and motivate others. Ability to drive projects to completion. Possesses a working knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of product labeling and packaging Ability to exercise sound judgment and operate with a high degree of independence regarding routine and non-routine assignments Possesses excellent written and verbal communication skills Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labeling

Minimum Requirements:

Bachelor's degree (preferably in a life sciences field) with preference to higher degree. Two to three years of relevant experience in the pharmaceutical industry, in one or more of the following areas: Regulatory project management, Regulatory labeling development, promotional product communications and/or review for prescription pharmaceuticals or similarly regulated industry required.

Flex Designation:

Remote-Eligible

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