Senior Manager, Global Labeling Strategy

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Position Summary The Senior Manager, Global Labeling Strategy, has overall accountability for relevant updates to labeling documents (e.g. Company Core Data Sheets [CCDS], United States Package Inserts [USPI] and EU Summary of Product Characteristics [SmPC]).

Position Responsibilities

• Drives labeling strategy in partnership with the Global Regulatory Leader (GRL) in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, internal processes, and competitor analyses) for CCDS, USPI and SmPC for low to medium complex projects, mainly at a Lifecycle Management (LCM) stage;

• Serves as primary contact for Labeling Strategy Team (LST);

• Works closely with counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical with LST, under management supervision;

• Serves as interface for Country Regulatory Managers to support timely and quality labeling submissions globally;

• Coordinates labeling activities of multifunctional contributors, reviewers and approvers as well as manages the label review and approval process to maximize speed and quality;

• Ensures effective planning of all cross-functional labeling activities;

• Support responses to labelling-related inquiries from Health Authorities and related to inspection activities;

• Reviews country labels to ensure labeling compliance;

• Participates in key initiatives (process improvements, development of new tools and technologies) to support efficient global label development and timely worldwide submissions and approvals.

Required experience and qualifications:

• Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of Lifesciences with at least 2 years of Regulatory and / or Regulatory Labeling Experience.

• Ability to understand regulatory implications of product strategy related to labeling development, assessment, and management;

• Ability to develop strong and positive working relationships across diverse teams and within a global environment;

• Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making;

• Experience in managing low-to-medium complex projects;

• Excellent verbal and written communication skills;

• Keen attention to detail and accuracy;

• Ability to assimilate clinical and scientific information and present it in a concise manner;

• Ability to think creatively and good problem-solving skills.

Ideal Candidates Would Also Have:

• Basic knowledge of regulatory labeling and labeling processes;

• Have labeling experience in at least one major region and CCDS;

• Have a basic knowledge of procedures, regulatory requirements and GxP;

• Good understanding of Drug Development and Commercialization of prescription medicines.

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview: Warsaw - PL: zł230,270 - zł279,037

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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R1601862 : Senior Manager, Global Labeling Strategy