Sr Manager/Team Lead, Labeling Operations

Pfizer • New York City, NY

1d • Hybrid

About The Position

ROLE SUMMARY: The Labeling Operations Manager/Team Lead will provide back up to Global & International Labeling Operations Head and will serve as a Global Labeling, Artwork, and U.S. Advertising & Promotion subject matter expert in areas related to general above country labeling operations. Will train and provide guidance and mentorship to other Labeling Operations Managers. The senior manager/team lead LOM will have direct reports or oversight of contractors and/or vendors. The Senior Manager/Team Lead LOM will have accountability for setting direction, leading pay, performance, goal setting, and development discussions for direct reports and manage vendor or contractor relationships for those contractors/vendors under their direct supervision. The Labeling Operations Manager (LOM) will lead and provide operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents. The Labeling Operations Manager, Senior Manager/Team Lead is capable of managing a large volume of projects which can be highly complex, including new development -NCE/NME, product enhancements, and updates that require extensive labeling discussions. The LOM can lead teams tasked with development of continuous improvement of business practices and/or technology innovations. The LOM will be a change champion and advocate for new labeling initiatives to labeling stakeholders across the portfolio and across the organizations. ROLE RESPONSIBILITIES: Lead and manage the review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents. Serve as the subject matter expert in areas related to general above country labeling operations. The Labeling Operations Manager, Senior Manager/Team Lead is capable of managing a large volume of projects which can be highly complex, including new development -NCE/NME, product enhancements, and updates that require extensive labeling discussions. The LOM will provide operational support: Edit and format labeling documents according to internal and external guidance. Independently manage updates for related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics. Prepare comparison tables for labeling team discussions. Coordinate and manage the Quality review process ensuring timelines are met and drive right first time principles. Generate necessary renditions (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate. Communicate with and notify key stakeholders of the labeling updates and/or availability of labeling documents. Create content of labeling xml (e.g. SPL for USPIs) and coordinate meta data/artwork sections with supporting lines. Draft/update related labeling document updates e.g., for products within a similar class, of different dosage forms, and for generics. Set clear targets for review and approval timelines for labeling documents using effective project management. Communicate with stakeholders to ensure deadlines are met. Consolidate and coordinate multiple labeling versions with different submission or HA review status. Responsible for ensuring compliance to Company’s submission standards, policies and procedures. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems. The Senior Manager/Team Lead, LOM will provide the following leadership support: Have direct accountability for onboarding, training, goal setting, deployment, and leading pay, performance, and development discussions of the direct reports. Have direct accountability for onboarding, training, and deployment, of the vendors and/or contractors under their responsibility. Manage vendor or contractor relationships for those contractors/vendors under their direct supervision. Promote the development of, and training opportunities for, the direct report/junior personnel, vendors and/or contractors as required. Responsible for project monitoring and ensuring that LOM tasks are performed per quality expectations, as per target timelines & in compliance with company standards, policies and procedures. Identify and direct teams to overcome barriers in achieving quality and compliance. Guide and assists team members to identify and assess regulatory risks associated with assigned projects and their timely communication to the team to quickly mitigate the risks. Drive resolution of issues. Communicates issues, impact and outcomes to management Remain knowledgeable about current regulations and guidance, interprets and implements in the assigned projects. Responsible for ensuring compliance to Company’s submission standards, policies and procedures. Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems. Lead teams tasked with development of continuous improvement of business practices associated with operational processes and tools. Support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals. Contribute and support the development of job aids and guidance documents.

Requirements

• Bachelor’s degree in a science or life sciences required
• 6+ years of experience in a regulated environment with a Bachelor’s degree OR 5+ years of experience with a Master’s Degree
• 4+ years pharmaceutical labeling experience
• Knowledge of global/regional regulatory guidelines and requirements
• Excellent written and verbal communication skills essential.
• Complete fluency in English Language.
• Proven strength in logical, analytical and writing ability essential.
• Demonstrated project management skills and attention to detail required.
• Identifies and resolves problems in a proactive manner.
• Project Management capability and organizational skills: Ability to assess and manage project timelines. Ability to multi-task, prioritize and manage multiple projects. Ability to independently identify and resolve problems in a proactive manner.
• Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders.
• Identifies existing process/product improvements
• Develops innovative, advanced new concepts that improve processes / products across own and related disciplines
• Takes appropriate risks to achieve desired results
• Interpersonal and communication skills: Ability to liaise with stakeholders using effective means of communication. Clear and effective written and verbal communication skills. Proven ability to effectively lead and train team members. Ability to develop training tools and author SOPs/Job Aids/Guidance documents.
• Solves complex problems, where previous experience outside of own area may be relevant.
• Uses communication to help ensure alignment within and outside of Sub Business Unit/Sub Operating Unit
• Creates and delivers presentations to direct reports and other internal stakeholders across Sub Business Unit/Sub Operating Unit.
• Provides input to senior management decisions that may have an impact on business direction within the Sub Business Unit/Sub Operating Unit
• People Management: Recognizes development needs and identifies/creates development opportunities (e.g., special assignments) for colleagues within own Sub Business Unit/Sub Operating Unit Develops a talent base and anticipates development needs within the area of responsibility. Manages performance of direct and indirect reports and support Sub Business Unit/Sub Operating Unit objectives through goal setting, ongoing assessment and coaching and performance evaluation.
• Technical competencies: Ability to apply labeling regulatory guidance on formatting requirements High attention to detail Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes). Advanced level of knowledge on general standards, processes and policies of Pfizer/ Pharmaceutical Regulatory Industry. Provides technical / functional leadership to teams Leverages technical/functional expertise across own and related disciplines. Demonstrates comprehensive industry knowledge. Exhibits business expertise and an understanding of the external marketplace and customer requirements. Actively shares knowledge with others across multiple Sub Business Unit/Sub Operating Unit through existing knowledge sharing processes/systems Encourages others to share knowledge across the organization. Prepares for and manages change that impacts the Sub Business Unit/Sub Operating Unit.
• Systems and Document compilation skills, including: Must have excellent computer skills and be proficient with Microsoft Word and similar applications. Prepare submission ready documents - Hyperlinking, pagination, Table of Contents (TOC) creation, etc. Knowledge of Labeling and Document Management systems.
• 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.
• This position requires permanent work authorization in the United States.

Responsibilities

• Lead and manage the review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents.
• Serve as the subject matter expert in areas related to general above country labeling operations.
• The Labeling Operations Manager, Senior Manager/Team Lead is capable of managing a large volume of projects which can be highly complex, including new development -NCE/NME, product enhancements, and updates that require extensive labeling discussions.
• Edit and format labeling documents according to internal and external guidance.
• Independently manage updates for related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.
• Prepare comparison tables for labeling team discussions.
• Coordinate and manage the Quality review process ensuring timelines are met and drive right first time principles.
• Generate necessary renditions (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
• Communicate with and notify key stakeholders of the labeling updates and/or availability of labeling documents.
• Create content of labeling xml (e.g. SPL for USPIs) and coordinate meta data/artwork sections with supporting lines.
• Draft/update related labeling document updates e.g., for products within a similar class, of different dosage forms, and for generics.
• Set clear targets for review and approval timelines for labeling documents using effective project management.
• Communicate with stakeholders to ensure deadlines are met.
• Consolidate and coordinate multiple labeling versions with different submission or HA review status.
• Responsible for ensuring compliance to Company’s submission standards, policies and procedures.
• Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
• Have direct accountability for onboarding, training, goal setting, deployment, and leading pay, performance, and development discussions of the direct reports.
• Have direct accountability for onboarding, training, and deployment, of the vendors and/or contractors under their responsibility.
• Manage vendor or contractor relationships for those contractors/vendors under their direct supervision.
• Promote the development of, and training opportunities for, the direct report/junior personnel, vendors and/or contractors as required.
• Responsible for project monitoring and ensuring that LOM tasks are performed per quality expectations, as per target timelines & in compliance with company standards, policies and procedures.
• Identify and direct teams to overcome barriers in achieving quality and compliance.
• Guide and assists team members to identify and assess regulatory risks associated with assigned projects and their timely communication to the team to quickly mitigate the risks.
• Drive resolution of issues.
• Communicates issues, impact and outcomes to management
• Remain knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.
• Lead teams tasked with development of continuous improvement of business practices associated with operational processes and tools.
• Support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
• Contribute and support the development of job aids and guidance documents.

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program
• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager