Vacancy has expired
Show me jobs like this one| Job Ref: | 2851254BIOS |
| Sector: | Business Partner Companies, Other |
| State: | Massachussetts (MA) |
| City: | Cambridge |
| Post Code: | Feb 01, 2012 |
| Job Description: |
The Sr. Director will be responsible for regulatory strategy and operational leadership in the area of product labeling and commercial communication for Vertex products and development programs, as well as management of regulatory affairs labeling and advertising/promotion staff. Key responsibilities include the following: * Responsible for leading activities related to processes, procedures and training to ensure that marketing and other commercial communication are in compliance with applicable laws, regulations and guidelines. * Represent the regulatory department with corporate senior management and provide direction and advice on regulatory issues specific to external communications and labeling. * Working closely with Marketing, Medical Affairs, Legal and others, the Sr. Director will be involved in the development of advertising and commercial communication materials that support corporate goals and comply with applicable FDA regulations. * Responsible for procedures for review, approval and submission of advertising and promotional materials to the FDA. * Serve as primary contact with FDA Division of Drug Marketing, Advertising and Communications (DDMAC). * Responsible for development of product labeling, including package inserts and core labels. * Monitor the external environment to advise Vertex on evolving regulatory requirements related to advertising, labeling and promotion, and will update appropriate company stakeholders and make presentations as needed on current regulatory issues, providing strategy and risk assessment analysis to stakeholders and senior management. * Develops long and short-term planning and management of regulatory projects consistent with departmental and corporate business plans. * BS in a life sciences field with a minimum of 10 years of experience in promotion, advertising and labeling regulatory affairs.. Preferred Qualifications: * An advanced degree (Master's degree, JD, PhD, PharmD or MD) is preferred. * Direct experience with Canadian regulatory authorities desired. Requirements See Job Description |
| Post Date: | 02/02/2012 |
