Director, Global Labeling, US job in Boston, USA

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Last Name*

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Job type: Permanent

Discipline: Senior/Director & VP, Project Manager, Labelling & Artwork

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Director, Global Labeling for a leading biotech company located in Boston, MA. The Director of Global Labeling will be responsible for the services provided by the artwork and labeling teams in the Center of Excellence based in the US.

Must be eligible to work in the US.

Job Responsibility:

Execute Artwork and Labeling strategy in alignment with the requirements of product portfolio and its lifecycle evolution.
Ensure compliance in the execution of the labeling operations worldwide and in alignment with the relevant and applicable regulations. (US and EU (CP, MRP, and DCP)
Establish and manage the Artwork and Labeling Center of Excellence in the US in alignment with the Center of Excellence in the EU.
Adhere and improve service and quality delivery guidelines and performance measures.
Provide expert advice on current labeling requirements applicable to the areas where we commercialize our products and future pipeline. This includes templates, tools, and Health Authority-issued guidance.
Participate in artwork digital strategy implementation, ensuring the tool suite delivers flawless results under the highest levels of quality and compliance.
Provide oversight for third-party providers of artwork and labeling outsource services as well as all other staffing providers in this space. This will be done applying best practices for the oversight of outsourced services and their performance from planning work to measuring execution against established SLAs, including right first-time metrics.
Actively participate in the development and implementation of regulatory labeling strategies for global implementation for our product portfolio.
Closely collaborate across key relevant functions in CMC, Commercial and Regulatory. Engagement with the Quality, Serialization, Master Data and Security teams will be required to ensure maximum levels of product security and traceability are applied to our products.

Skills and Requirements:

Demonstrated technical knowledge of the end-to-end labeling and artwork areas processes in the pharmaceutical industry
In depth knowledge of the applicable regulatory environment, and applicable compliance elements associated with the execution of the labeling and artwork services.
Demonstrated knowledge of global health authorities' requirements applicable to labeling operations across all aspects of the product lifecycle management including regulatory submission, approval, and commercial labeling for major markets along with pharmaceutical requirements and practices.
Ability to manage key transformation and digital programs aimed to improve the labeling operations
Leadership of global teams (vision, strategy and business alignment, people management, communication, influencing others, managing change)
Excellent and proactive communicator, with the ability to deliver technical concepts in an effective and tailored way to technical audiences and to executive leadership. This includes proposals and root cause investigations of issues (including proposals and data analysis)
Drive effective decision making on key design elements associated to global labeling operations while effectively articulating pros and cons of the various alternatives.
Bachelor's degree Business Administration, Engineering, Mathematics, Supply Chain, or related field of study. MBA preferred.
10+ years' experience in Pharmaceutical or Medical Device industry, with 8 years in Regulatory Affairs, labeling or quality assurance/compliance.
Demonstrated thorough understanding of pharmaceutical drug development and global regulations pertaining to labeling artwork, drug development, and commercialization of medicines
In depth expertise on global labeling requirements and guidance governing drugs and biologics labeling in all phases of development globally with emphasis in those applicable to the United States and the Americas
Practical experience applying packaging regulations and processes associated with the creation, approval, issuance, and review of labeling artwork for all aspects of commercial products' lifecycle.
Demonstrated experience managing third party providers of labeling outsourced services.
Knowledge of best practices on digitalization of labeling artwork in the pharmaceutical industry, including management of Artwork Management Systems.
Expertise in structuring centers of excellence and the formulation of services to internal customers adhering to the concepts of operational excellence and continuous improvement.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or n.walker@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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