The Vertex Medical Writing department is a collaborative team of about 25 people who are responsible for preparing clinical regulatory documents to support development programs throughout the product lifecycle. Medical Writers are key members of study teams and submission teams.
The Director will be a strategic, hands-on medical writing expert with responsibility for leading and managing a team of writers and for preparing high-quality clinical regulatory documents. The Director will contribute both strategic and operational perspectives. The Director will make significant contributions to department initiatives and will collaborate with key functions across the organization.
This role will report to the Head of Medical Writing and will be a key member of the Medical Writing leadership team. This will be a full-time, onsite role located in Boston, MA.
- Advise teams on the content and presentation of clinical regulatory documents
- Participate as a member of team involved in defining the direction of the clinical development program or regulatory strategy
- Collaborate with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on program objectives
- Optimize interdisciplinary understanding and integrate activities with those of other departments and project teams
- Predict and plan resource requirements and staffing needs, ensuring appropriate staff are available to meet program goals
- Participate in developing and implementing processes and templates to ensure efficient preparation of high quality medical writing deliverables
- Provide input to strategies and tactics for the Medical Writing department
- Oversee hiring of staff; provide coaching and performance management
Minimum Qualifications :
- PhD (or equivalent degree) and 7+ years of relevant work experience
- Experience authoring clinical regulatory documents
- Leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA)
- Experience managing direct and indirect reports, including medical writing contractors
- Ability to plan, manage, and optimize resources
- Strong leadership and influencing skills
- Attention to detail