Associate Director, T1d International Launch
6 months ago
Job Description
General Summary:
The Associate Director, International Launch Execution T1D will be responsible for the initiation and project management of launching Vertex T1D products in the International region by leading cross -functional team having members from Commercial, Finance, Regulatory, Quality and CMSC groups. This role will further include product lifecycle management of Vertex T1D products.
This is a hybrid role based in Paddington, London.
Key Duties and Responsibilities:
- Create the Launch Strategy and initiate implementation plans related to launches and later to product lifecycle management for International T1D operations.
- Coordinate with cross-functional stakeholders and ensure to capture all relevant information to understand the specific requirements for every country and (in
- and external) customer perspective
- Be the CMSC responsible for International T1D of product launch process and drive them to the finish line in a timely manner. Continuously ensure adherence to relevant procedures and processes.
- Lead project management activities by scheduling and hosting meetings, align with and gather information from project team members, follow up and driving timely execution of actions items, publish meeting minutes, etc.
- Own and drive progress for relevant Quality Management System (QMS) change controls related to product lifecycle management and projects.
- Regular reporting of status, and escalate issues to the Sr Director, International CGT Supply Chain.
Knowledge and Skills:
- Specialized depth of knowledge on regulations relating to pharmaceutical supply chain activities (cGMP, GCP, GDP, import/export, computer systems/Part 11)
- Very strong analytical and problem solving skills, often addressing novel/unusual situations and exercising judgement
- Highly skilled at preparing and presenting informational and compelling reports, delivering to a variety of audiences
- Excellent ability to collaborate with other functional areas and build effective, productive business relationships
- Significant project management skills and highly proficient at managing, tracking, and measuring
- Technical know ledge of biotech and/or pharmaceutical product launches and working knowledge of regulatory requirements are considered a plus
- Familiarity with Cell and Gene Therapy programs or short lead time cold chain operations preferred project progress; projects are dynamic and complex, requiring new perspectives and sophisticated analytical thought
- Displays proven effectiveness in managing customer expectations, communicating in complex or sensitive situations, facilitating mutually beneficial outcomes and influencing/guiding others to adopt a new point of view
- Highly proficient with use of applicable software systems
- Experience in building and managing high-performing teams
Education and Experience:
- Bachelor's degree in a scientific or business discipline
- Experience in supply chain or the equivalent combination of education and experience
LI-SM1
LI-hybrid
Company Information
- Vertex is a global biotechnology company that invests in scientific innovation.
- Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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