Associate Global Labelling and Systems Director

Associate Global Labeling and Systems Director

SUMMARY: 

This position will champion the design, establishment, and management of all global labeling development and printing for growing and expanding portfolio of programs. Reporting to the VP of Clinical Supply Chain, and with a focus on end to end labeling, this individual will identify best practices and strategies and external third party vendors for the introduction, evaluation and implementation of improvements to the existing labeling process, systems, and policies, while leading efforts in enhancement of key and related systems and processes within supply chain and pharm ops where internal processes and technological solutions are required.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Responsible for the design and management of the systems, processes, and operations for development of and changes to global labels
  • Leads the establishment of cross-functional end to end labeling processes within the company through cross-functional stakeholder partnership participation to ensure adequate compliance.
  • Lead the establishment of direct label printing at third party vendors to directly manage and oversee the printing of labels to ensure timelines for clinical supply labeling are exceeded at CMO’s.
  • Identify and oversee third party vendors for global translation processes and regulatory certification of clinical labels for multiple phases of global clinical trial programs
  • Works closely with the clinical supplies team in order to ensure that product labeling timelines are exceeded through label content design, mockups, print proofs and printed labels in advance of clinical supply labeling needs
  • Works closely with clinical supplies, regulatory, clinical operations and quality teams to ensure that labels are available for any country specific submission submissions and health authority responses.
  • Ensures that appropriate label content is included in product labels, pharmacy manuals, protocols and all other associated documents as applicable for existing and new programs
  • Is knowledgeable about printing methods and techniques, materials sourcing and serves as senior contact for CMOs, labeling vendors/printers to resolve issues related to labeling under development, revision or reorder
  • Continually monitor and evaluate the current regulatory environment in order to provide guidance and develop regulatory strategy for labeling content development with internal and external stakeholders.
  • Identifies and champions process improvement initiatives within clinical and commercial supply chain related to labeling and other systems
  • Leads identification of software (i.e. printers, translators, proofing, etc.) evaluation and selection
  • Represents PSC with internal stakeholders and partners regarding all label changes
  • Establishes internal controls for label print materials to ensure that external CMO’s are following allowable procedures
  • Applies expert working knowledge of 21 CFR 201 and related FDA guidance as well as global company labeling standards and applies understanding to business situations.
  • Write and review departmental SOPs and ensure updates and compliance with industrial standards.
  • Authors and reviews SOPs required for clinical labeling activities to ensure GMP compliance.
  • Collaborates with internal and external labeling stakeholders including quality, regulatory, pharmaceutical operations, and marketing. Assures that cross-functional teams are operating according to approved company processes. Advises teams on best practices regarding planning and execution for the development of new and changing labeling.

SUPERVISORY RESPONSIBILITIES:

  • No immediate line management responsibility.

EDUCATION/EXPERIENCE/SKILLS: 

Education:

  • BS/BA degree in related discipline and at least 10 years of related experience; or,
  • MS/MA degree in related discipline and at least 8 years of related experience; or,
  • The equivalent combination of education and experience.
  • Certification in assigned areas is a plus.

Experience:

  • At least 14 years pharmaceutical industry experience with a minimum of 8 years experience in pharmaceutical label generation, systems, translations and printing
  • Demonstrated expert proficiency in managing and control of pharmaceutical labeling in accordance with local and global regulatory requirements, e.g., CCDS management. Experience with US regulatory and compliance requirements for labeling and operational aspects at manufacturing locations.
  • Strong understanding of FDA and other country Health Authority regulations and guidelines with the ability to interpret and apply them
  • Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development having technical complexity.

Knowledge/Skills/Abilities:

  • Demonstrated experience developing strategy for product labeling
  • Able to communicate effectively and maintain effective working relationships. Must be able to effectively influence peers and others within the organization.
  • Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
  • Excellent written and verbal communication skills (native and non-native English speakers) with the ability to meet regulatory requirements and standards while maintaining effective relationships.
  • Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.
  • Initial scope will be clinical, but this may expand to include marketed products too, so having experience with labeling requirements for commercial products is a plus
  • Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality, and Pharmaceutical Operations functions to ensure high customer satisfaction.
  • Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
  • Knowledge of primary and secondary packaging used for small molecule and biologic products
  • Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding labeling regulations and guidelines.
  • Willingness to work in a fast paced, evolving environment.
  • Clinical Supply management experience using contract manufacturing companies strongly preferred.
  • Knowledge of GMP batch record development, review, and approval processes.
  • Working knowledge of regulations relating to clinical labeling, packaging and distribution activities.
  • Working knowledge of GMP/GCP/GLP regulations required.
  • Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways.
  • Excellent project management and communication skills.

 

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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