Associate Director, Regulatory Labeling Strategy (Remote)

Job Description

GENERAL POSITION SUMMARY:

The Global Labeling Lead - Development Labeling will support development labeling for assigned early-stage pipeline programs/products, with oversight from the Development Labeling Lead. This role has responsibility for leading labeling strategy and coordinating development of the Target Label Profile (TLP) with the cross-functional team. This role will also be responsible for coordinating creation of the initial Company Core Data Sheet (CCDS), Prescribing Information (PI) and Patient Information Leaflet (PIL) in select markets (typically US and EU), to support MAA/NDA/BLA submissions.

This position reports directly to the Development Labeling Lead.

KEY RESPONSIBILITIES:

The responsibilities of this position may include, but are not limited to, the following:

• Coordinate development of the TLP, CCDS and regional labels for one or more pipeline programs/products.
• Conduct research related to labeling precedent, regional regulations, policies, and other topics, as necessary, to advise on potential labeling impact, strategy, or outcome.
• Lead the Label Working Group (LWG) for assigned programs/products and represent the group at governance meetings.
• Provide input into strategy for Health Authority interactions regarding all aspects of labeling, including submissions, responses to questions, and negotiations.

Expected knowledge and skills include, but are not limited to, the following:

• Experience that demonstrates ability to create development labeling (TLP, initial CCDS) from available resources.
• Ability to research and understand complex scientific and regulatory information and distil important aspects for impact to labeling.
• Ability to plan, prioritize, lead, and execute individual work, and teamwork related to regulatory labeling in a systematic and efficient manner.
• In-depth and practical knowledge of labeling requirements globally, including development and life-cycle management of local PIs and PILs.
• Experience in the development of Instruction for Use (IFU) documents is preferred, but not required.
• People management experience is preferred, but not required.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree
• Typically requires 8 years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience.

#LI-EE1  #LI-Remote

Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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