Job Title: Manager Global Labeling Strategy
Department Name: Global Labeling, Global Regulatory Affairs
The Global Labeling Team at Vertex is seeking a highly motivated Manager of Labeling Strategy, who understands strategic global labeling. They will have an ability to develop strong matrix working relationships and will be responsible for supporting the Global Labeling Lead (GLL) in collaboration across the global regulatory affairs department and with cross-functional experts to develop global labeling strategies for marketed products. A pro-active individual, the Manager of Labeling Strategy will have an ability to lead, influence and work collaboratively.
- Reporting into the Global Labeling Lead, the Manager of Labeling Strategy will represent Global Labeling at product-specific global regulatory teams, labeling working groups and labeling governance committee meetings.
- Manage complex labeling projects, including the development, review and approval of the Company Core Data Sheet (CCDS), European Summary of Product Characteristics and US Prescribing Information, as well as acting as a subject matter expert to provide strategic labeling advice for other regional labels.
- The Manager of Regulatory Labeling will conduct, summarize and present research on labeling precedent and labeling and regulatory regulations.
- Experience managing the life-cycle management of global or local labeling.
- Knowledge of labeling regulations and guidance’s governing drug development and maintenance in major markets (EU, US and Canada etc).
- Clear and effective written and verbal communication skills, project management and presentation skills (articulate and persuasive). Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
- Team player with the ability to establish and maintain strong relationships with all functional areas of the local and global organization.
- Ability to collaborate effectively with peers, within global teams.
- Bachelor’s degree (preferably in a life sciences field) with preference to higher degree.
- Relevant experience in Regulatory Affairs in the area of labeling development, promotional product communications and review for prescription pharmaceuticals or similarly regulated industry required.
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. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.