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| Vertex Pharmaceuticals |
Cambridge |
MA |
9/6/2010
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| Labeling Manager, Regulatory Affairs |
| * Bachelor?s degree (preferably in a life sciences field)
* Three to five years of relevant experience in Regulatory Affairs in the area of labeling development and review
* A strong knowledge of US and ex-US technical labeling aspects such as SPL/PIM, PLR, the basic printing process, and regulatory barcode requirements
* Possesses excellent written and verbal communication skills
* Excellent organizational, analytical, problem-solving, proofreading, and decision-making skills
* Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labeling.
* Working knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of product labeling and packaging
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain.
Vertex Pharmaceuticals |
| Vertex Pharmaceuticals |
Cambridge |
MA |
9/6/2010
|
| Director, Clinical Operations |
| * Global experience within all phases of drug development with advanced understanding of other functions; including but not limited to: Research, Non-Clinical, Supply Chain, Commercial, Regulatory and Medical Affairs
* Experience in strategic planning, business process improvement and achieving results.
* Experience in demonstrating leadership and influence and collaboration in a matrix environment
* Application of Project Management tools, methodologies, practices, risk analysis, decision analysis and contingency planning
* The ability to effectively communicate with Clinical Leadership and Clinical Project Managers
* Strong consultative, listening and analytical skills
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company?s strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex?s product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection.
Vertex Pharmaceuticals |
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