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Senior Manager Global Labeling Strategy

4 months ago

Tampa, United States TSR Consulting Full time
About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee's voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Senior Manager Global Labeling Strategy

Job Description

  • Location: Tampa, Florida
  • Type: Contract
  • Job #79211
Our client, a leading pharmaceutical company, is hiring a Senior Manager on a contract basis.

Job ID #: 79211

Work Location:
Tampa, FL - 100% on site

Summary:
Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the centralized, Mutual Recognition or Decentralized Procedure.

Knowledge/Skills/Education:
  • Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of Life Sciences with 2 years of Labeling / Regulatory Experience.
  • Good Understanding of Drug Development and Commercialization of prescription medicines
  • 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 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 excellent problem-solving skills.
Responsibilities:
  • Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory Strategy by providing labeling expertise (labeling regulations, internal processes and competitor analyses) for CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentralized Procedure) for medium to low complex projects in the Lifecycle Management (LCM) projects.
  • Serves as primary contact for Labeling Strategy Team (LST), eg Global Regulatory Lead (GRL), Safety Management Team Lead (SMTL), Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead and Submission Manager, also serves as interface for Country Regulatory Managers to support timely and quality submissions globally.
  • Coordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality.
  • Ensures effective planning of all cross-functional labeling activities.
  • Reviews country labels to ensure labeling compliance.
  • Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities.
  • Participates in key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.