Director, Clinical & Regulatory Medical Writing (Hybrid)

Job Details:-

This is a job posting from company – Vertex Pharmaceuticals

Employment TypeFull Time

Work Hours: 8

Salary: $20 To $30/An Hour

Location: Massachusetts, USA

This job is 100% remote.

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Job Description

General Summary:

The Director, Medical Writing has responsibility for the management, oversight, operation, and direction of a group within the department. This role is held accountable for the results of the group and the work performance of line staff and is responsible for setting technical direction for the staff. This role is expected to optimize interdisciplinary understanding and teamwork and integrate activities with those of other groups in Medical Writing Science and with other functions.

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
  • Sets goals and strategic vision for the group shares that vision within Medical Writing Science
  • 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 performance management for staff, ensuring goal setting is effectively linked to program and corporate goals
  • 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
  • Ability to manage teams and individuals
  • Experience with marketing applications for regulatory submissions

Education and Experience:

  • Bachelor’s degree in relevant discipline
  • Ph.D. (or equivalent degree)
  • Typically requires 10 years of work experience and 3 years of supervisory/management experience, or the equivalent combination of education and experience


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.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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 [email protected]

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