Senior Director, Medical Writing Science

Job Description

General Summary:

The Senior Director, Medical Writing Science has responsibility for the management, oversight, operation, and direction of a larger group within the department. The Senior Director is a key stakeholder working with cross-functional teams to provide scientific, clinical, and strategic input throughout the lifecycle of an asset. This role may be responsible for multiple programs and/or disease areas, including executing strategic clinical regulatory and scientific publications and for defining cross functional goals and plans.

Key Duties and Responsibilities:

• Oversight of Medical Writing Science team responsible for the development of clinical documents, regulatory documents, and scientific publications (abstracts, posters, oral presentations, manuscripts) across the lifecycle of an asset

• Provides scientific, clinical, and strategic input for an asset(s) in clinical development within a portfolio for one or more disease areas

• Provides strategic input to global marketing authorization applications and responses to health and regulatory authorities

• Provides expertise and input to help author and communicate visually compelling scientific publications for medical congresses and journals

• Leads internal governance bodies with high cross-functional impact (e.g., Protocol Governance Committee)

• Represents Medical Writing Science in Inspection Readiness and participates in GCP Audits and Inspections

• Mentors staff on professional development, motivates personnel, and resolves conflicts

• Manages resource plans for programs within their oversight ensuring appropriate staff are available to meet program goals

• Advises on optimizing process improvements for the department

• Plans strategically, anticipates problems, and recommends process improvements to address current and future needs

Knowledge and Skills:

• In-depth knowledge of industry requirements and best practices policies for clinical regulatory documents and scientific publications (e.g., GCP, GPP, ICH, ICMJE)

• Robust understanding of the clinical development process and preparation of the clinical sections of marketing applications and other regulatory submissions

• Robust understanding of disciplines beyond their discipline

• Distinguished record of developing, communicating, and executing strategic direction for projects

• Effective leadership skills with ability to influence at higher levels

• Excellent written and oral communication skills

• Ability to manage teams and individuals

Education and Experience:

• Typically requires Ph.D. in a relevant scientific field

• Typically requires 12 years of work experience and 5 years of supervisory/management experience, or the equivalent combination of education and experience

Flex Designation:

Flex Eligibility Status:

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.

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