Clinical & Regulatory Medical Writing Director (Hybrid))

Job Description

Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients.

The Medical Writing Director has responsibility for the management, oversight, operation, and direction of Clinical Regulatory Writing in support of our Pain program. This role is expected to optimize interdisciplinary understanding & teamwork, and integrate activities with those of other groups in Medical Writing Science and cross-functional teams.

This is a hybrid position which allows for 2 days per week remote work, and 3 days per week onsite at our Boston Fan Pier office.

Key Duties and Responsibilities:

• Independently authors routine and complex clinical and regulatory documents
• Advises development teams on the content and optimal presentation of documents to facilitate achievement of submission objectives
• Provides strategic input into program-level and therapeutic area plans, including defining the direction of the clinical development program or regulatory strategies
• Optimizes interdisciplinary understanding and synergy within group(s) and integrate activities with those of other department and project teams
• Manages resource plans for projects within their oversight ensuring appropriate staff are available to meet program goals
• Provides coaching and mentorship for junior staff members
• Plans strategically, anticipates problems, and recommends process improvements to address current and future needs
• Provides expert review of policies and procedures for the department
• Innovates and leads process improvements with high cross-functional impact

Knowledge and Skills:

• Highly advanced understanding of the clinical development process and preparation of the clinical sections of marketing applications and other regulatory submissions
• Proven track record of developing, communicating, and executing strategic direction for projects
• Strong leadership and influencing skills, ability to communicate and present ideas/solutions to senior management
• Ability to recognize business impact and identify networks to gain unified approach to solutions
• Demonstrated knowledge of field
• Experience with marketing applications for regulatory submissions

Education and Experience:

• Ph.D. (or equivalent degree)
• Typically requires 10 years of work experience and 3 years of mentorship/supervisory experience, or the equivalent combination of education and experience

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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