Global Labeling Lead, Sr Manager

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines .

What You Will Achieve

You will manage and direct the development and maintenance of labeling and artwork for product registration and commercialization. In your role, you will serve as a regulatory liaison between markets, manufacturing plants and/or project teams throughout the product lifecycle and provide advice on manufacturing changes, line extensions, technical labeling and appropriate interpretation of regulations. You will be accountable to provide strategic direction to local and global stakeholders on labeling and artwork content, regulatory requirements and logistics.

As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.

It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe .

How You Will Achieve It

• Develop ideas and lead projects across the division and develop plans to achieve objectives.
  
• Lead operational team(s) within and across work teams and departments, taking responsibility for the team's milestones and deliverables.
  
• Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of products and their associated Patient l abeling d ocuments.
  
• Engage in and contribute to Labeling Team discussions around content and format of the labeling documents.
  
• Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines and company.
  
• Meet strategic targets for labeling deliverables as defined for the function and communicates progress against these targets or issues which affect these targets and proposes remediation.
  
• Understand and apply labeling regulation in the region and in assigned local countries and interpret impact of that regulation on development of labeling text.
  
• Mentor, train or supervise more junior labeling managers in their day-to-day activities and may review work completed by other colleagues.
  
• Lead regional Subject Matter Experts ( SME ) forums on labeling processes and clearly articulate expectations of the labeling process to a broad range of stakeholders.
  
• Interpret internal/external business challenges and best practices to recommend improvements to products, processes, or services.
  
• Understand of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverables.
  
• Review and approve labeling documents ensure that content complies with regulatory requirements and guidelines and company policies and procedures and that the label content can be incorporated .
  

Qualifications

Must-Have

• Bachelor's Degree (BA/BS) and 9+ years of experience.
  
• Demonstrated project management, attention to detail and problem solving skills.
  
• Knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.
  
• Understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
  
• Excellent written and verbal communication skills essential.
  
• Ability to negotiate, influence and problem solve .
  

Nice-to-Have

• Master's degree (MA/MBA/MS) and 7+ years of experience.
  
• Doctorate (PhD/PharmD/JD) with 4+ years of experience.
  
• Knowledge of Clinical Variations.
  
• Demonstrated project management, attention to detail and problem solving skills required .
  

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Regulatory Affairs

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