For over 30 years, PAREXEL has proven to be a trusted partner for the complex development journey required of biopharmaceutical and medical device companies. We’re also an astute guide, able to simplify that journey for our clients, so safe new products can reach patients more quickly.
Job Title : Manager, Medical Writing Services
Essential Function
The Manager, Medical Writing Services, will research, create, and edit documents associated with the clinical sections of regulatory submissions and other clinical documents. This is a billable position (65%). The Manager is also responsible for all line management of assigned medical writing staff, either at the local site or remotely. The Manager inputs to medical writing resources for proposals. The Manager provides project management of the medical writing aspect for their projects and those of their line reports.
Education : Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent.
Key Accountabilities include the following main areas:
- Writing and consultancy
- Project management
- General management
- Line management
- Process improvement
- Training
- Client liaison/service
- Resource planning
- Proposals
Skills
• Excellent interpersonal, negotiating, verbal and written communication skills.
• Professional attitude.
• Client focused approach to work.
• Client liaison.
• A flexible attitude with respect to work assignments and new
• Logical thinking.
• Attention to detail.
• Self-motivated to work consistently in a fast-paced, rapidly changing environment.
• Able to work independently.
• Able to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company.
• Supervision/demonstrated understanding of people management.
• Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
• Project management (planning and monitoring).
• Business awareness/business development.
• Knowledge of resource management and productivity metric management.
• Advanced word processing skills, expertise in Word for Windows, ability to understand and adapt to various IT systems.
• Ability to travel.
Language Skills
- Fluent in written and spoken English.
- Broad experience in management of complex medical writing projects, including phase III. Previous line management experience, or equivalent, preferably in a billable service industry.