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Manager, Global Labeling Compliance and Operations-Remote Eligible

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Vertex Pharmaceuticals

Sep 4

  • Job
    Full-time
    Senior & Expert Level
  • Quick Apply

AI generated summary

  • You need knowledge of pharmaceutical labeling regulations, strong project management skills, experience in compliance, and excellent communication abilities. A life sciences degree and industry experience are essential.
  • You will support regulatory labeling for ROW markets, manage artwork and label changes, author response documents, oversee compliance, and drive process excellence while liaising with vendors.

Requirements

  • - 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
  • - Excellent planning, organizational, analytical, problem-solving, proofreading, and decision-making skills
  • - Experience leading process improvement projects
  • - Experience managing projects or coordinating multiple activities at once
  • - Ability to lead and motivate others
  • - Ability to drive projects to completion
  • - 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
  • - Experience with pharmaceutical labeling regulations in ROW markets, with a focus on Middle East, Asia, and Balkans (non-EU member countries) is desirable
  • - Experience in Quality Management Systems for change control, deviation and CAPA management
  • - Experience in use of RIM management system is desirable
  • - Experience with label tracking tools is desirable
  • - Bachelor’s degree (preferably in a life sciences field) with preference to higher degree
  • - Extensive 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

Responsibilities

  • - Support the Regional Labeling Lead (RLL) in the development and maintenance of regulatory labeling priorities and timelines for ROW markets.
  • - Collaborate with artwork and other stakeholders to identify requirements and develop initial submission labeling artwork for new markets.
  • - Management of the ROW packaging and labeling creation, review, endorsement through labeling governance and approval.
  • - Author regulatory response documents for package component labeling responses in ROW countries.
  • - Collaborate with artwork and supply chain stakeholders to plan and implement label changes.
  • - Provide regulatory labeling impact assessments for ROW change control records.
  • - Ownership of labeling deviations and CAPA's for ROW markets.
  • - Support the Regional Labeling Lead (RLL) in the development of the regional product labeling as needed, and for the tracking and archiving of key documents.
  • - Responsible for the process and communication of approved labeling to ROW markets to support HCPs.
  • - Proofreading and departmental QC, as needed.
  • - Liaise with vendors to, as needed, to obtain support for ROW Labeling for services such as translations.
  • - Manage departmental projects to pursue process operations excellence (includes associated SOP and WI development and maintenance).
  • - Accountable for oversight of compliance with global labeling processes and supporting associated regional labeling for inspection readiness. This includes tracking of package component labeling updates and internal labeling content deviations as well as maintenance of controlled records.

FAQs

What is the main responsibility of the Manager of Global Labeling Compliance and Operations - ROW?

The main responsibility is to ensure labeling is compliant with regulatory requirements and global labeling processes, while providing support for inspection readiness and overseeing regional product labeling management.

What are the key skills required for this position?

Key skills include excellent planning and organizational skills, the ability to lead and motivate others, experience with process improvement projects, strong written and verbal communication skills, and familiarity with labeling regulations in ROW markets.

What type of experience is needed for candidates applying for this role?

Candidates should have extensive experience in the pharmaceutical industry, particularly in regulatory project management, regulatory labeling development, or promotional product communications for prescription pharmaceuticals.

Is a specific educational background required for this position?

Yes, a bachelor's degree, preferably in a life sciences field, is required, with a preference for a higher degree.

Will the Manager of Global Labeling Compliance and Operations - ROW work independently?

Yes, the position requires the ability to exercise sound judgment and operate with a high degree of independence regarding routine and non-routine assignments.

What is the reporting structure for this position?

This position will report to the Global Head of Regulatory Labeling Compliance and Operations, GRA.

Is there an opportunity to work remotely in this role?

Yes, this is a remote-eligible role, with options for remote, hybrid, or on-site work arrangements.

How does Vertex handle equal employment opportunities?

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to any protected characteristic.

Are there any specific regions of expertise desirable for this role?

Yes, expertise in pharmaceutical labeling regulations in ROW markets, particularly in the Middle East, Asia, and Balkans (non-EU member countries), is desirable.

Will the role involve managing vendor relationships?

Yes, the role includes liaising with vendors for support related to ROW labeling services, such as translations.

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Vertex Pharmaceuticals

The Science of Possibility

Science & Healthcare
Industry
1001-5000
Employees
1989
Founded Year

Mission & Purpose

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.