Director, Medical Writing (Hybrid)

Vertex Pharmaceuticals•Boston, MA

3d•Hybrid

About The Position

Our Medical Writing team at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams, authoring and driving clinical & regulatory documents to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available. The Director, Medical Writing Science 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.

Requirements

Highly advanced understanding of the clinical development process and authoring 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
Bachelor's degree in relevant discipline
Typically requires 10 years of relevant medical writing experience in Pharma, Biotech or CRO industries and 3 years of supervisory/management experience, or the equivalent combination of education and experience

Nice To Haves

Ph.D. (or equivalent degree) highly preferred

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