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Global Labeling Lead (Manager)

Employer
Pfizer
Location
Remote, New York
Salary
Competitive
Closing date
Aug 22, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager
Organization Type
All Industry, Pharma
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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 Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts, and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

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

How You Will Achieve It
  • Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the department.
  • Support the use and development of current and new tools, technologies, and processes to support global label development, submission, and approval.
  • Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements.
  • Liaise and present information to all stakeholders using the most effective means of communication.
  • Review and develop appropriate content for local labeling documents based on existing approved content, seeking strategic and medical input from others as required.
  • Review request for labeling updates and appropriate implementation of defined content, recording the key decisions made.
  • Serve as an SME for the use of relevant tools and technologies within the course of the label development and translation process.
  • Work within a framework of internal SOPs, working practices and external regulatory requirements, so that the high-quality delivery of outputs and compliance is maintained.
  • Support the use of relevant tools and technologies within the course of the label development and translation process.
  • Contribute to the development of continuous improvement of business practices associated with processes and tools.
  • Advocate for new labeling initiatives to immediate labeling stakeholders (e.g., Labeling Teams) .


Qualifications

Must-Have
  • Bachelor's Degree (BA/BS) and 5+ 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 .


Nice-to-Have
  • Master's degree (MA/MBA/MS) and 3+ years of experience.
  • Doctorate Degree (PhD/PharmD/JD).
  • Demonstrated project management experience.
  • Attention to detail and problem solving skills.
  • Ability to negotiate, influence and problem solve .

Work Location Assignment: Remote

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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

#LI-Remote #LI-PFE
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