(Labelling and CCDS)Operations/Project Management - Systems Analyst II

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Job Title : Operations / Project Management - Systems Analyst II

Work Location : US 100% Remote The Global Labeling Strategist for Early Asset has overall accountability for initial creation and relevant updates to labeling documents (Target Label Profile (TLP), 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.

Responsibilities :

Drive the labeling strategy to early development activities to ensure consideration of labeling in claims development programs. Ensures that the labeling strategy is aligned with the overall product regulatory, registration, commercial and development strategy.Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, and competitor analyses) for Target Product Labeling, CCDS, USPI and SmPC for high complex projects in the Development and Lifecycle Management (LCM) projects.Serves as primary contact for cross-functional Labeling Team Member (CFLT), e.g. Global Regulatory Team Lead (GRTL), Medical Surveillance Team Lead (MSTL), 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.Contributes from the labeling perspective / labeling environment to Clinical Study designs, protocols, Investigator Brochures, and Briefing Books.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.Review country labels to ensure labeling compliance and adequacy to the regulatory strategy.Train and provide guidance for other Global Labeling Leads as needed.Participates in / Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.Identifies opportunities to influence regulatory policy and climate with respect to labeling content.

Requirements : Masters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 5 years of Labeling Experience (CCDS / USPI / SmPC) or Bachelor of Life Sciences and at least 7 years of Labeling / Regulatory ExperienceKnowledge of Global Labeling Guidance, Drug Development and Commercialization of prescription medicinesUnderstanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDSGood knowledge of pharmaceutical drug development.Previous experience with Health Authorities bodiesProven understanding of the dynamics and purpose of the Target Product Labeling and Company Core Data Sheets (CCDS) and their implicationsExperience in developing of Target Product Labeling Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling.Proven ability to understand regulatory implications of product strategy related to labeling development, assessment, and management.Demonstrated 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 high to medium complex projects.Excellent project management, verbal, and written communication skills

• Keen attention to detail and accuracy, coupled with the ability to think strategically.Ability to assimilate clinical and scientific information and present it in a concise manner and translate them into labeling content.Ability to think creatively and good excellent problem-solving skills.Time management skills

Jennifer Sampson

Technical Recruiter

DONATO TECHNOLOGIES, INC

12100 Ford Rd, #306, Dallas, TX 75234

Direct : (214) 738-0410

Email : Web :

DONATO TECHNOLOGIES WAS FOUNDED IN 2012, WE SPECIALIZE IN STAFFING, CONSULTING, SOFTWARE DEVELOPMENT, AND TRAINING ALONG WITH IT SERVICES

INFORMATION TECHNOLOGY REMAINS OUR STRENGTH!

We partner with clients, appreciate, and understand their business needs and bring them the most innovative and relevant technology solutions available.

Our experience has made us who we are today. We have partnered with a lot of clients and built technology that powers their business.

Careers

At Donato Technologies, Inc., we unite top-tier talent within a creative, collaborative, and supportive atmosphere, transforming daunting challenges into enjoyable and rewarding pursuits.

As a valued member of our team, you'll experience unparalleled opportunities to engage with both clients and cutting-edge technology.

We serve as the ultimate destination for talented individuals with aspirations and ambitions, addressing companies' growth needs comprehensively. We hold our clients, consultants, and talent in the highest regard.

If you're prepared to embark on a career in the technology fast lane, Donato is your ideal destination.