Job Description

At Vertex, our Clinical Regulatory Medical Writers are strategic scientific partners in the drug development process, collaborating with cross-functional teams to bring new, life-changing products to market.

The Associate Director, Clinical regulatory Medical Writing manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments.

Key Duties and Responsibilities:

• Independently authors routine and complex clinical and regulatory documents
• Provides strategic input into program-level plans
• Deep insight into how different functions contribute to the successes of the team
• Aligns, coordinates, and builds consistent information and messages across clinical program(s)
• Provides leadership related to the activities of Medical Writing Science and manages a team
• Participates in developing and implementing goals and initiatives for Medical Writing Science
• Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents
• Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements

Knowledge and Skills:

• Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives
• Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues
• Proven track record of anticipating potential problems and preparing contingency plans as needed
• Understanding of scientific disciplines beyond own specialty area
• Experience managing direct reports and guiding staff development
• Experience with marketing authorization application regulatory submissions

Education and Experience:

• Ph.D. in a relevant field
• Typically requires 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience

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Company Information