Director Medical Writing
- Experience Level
- Experienced (non-manager)
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
- Ensure that the Medical Writing staff is adequately trained and capable of delivering high quality documents to internal and external clients.
- Develop a sense of teamwork and common purpose among the staff, especially among the writers, but extending to the entire Medical Writing group.
- Ensure excellent communication and interaction within the Medical Writing team and between Medical Writing and the wider teams within Covance.
- Support the Head of the group on short-term and long-term strategies to improve efficiencies in the department.
- Predict and plan resource requirements and staffing needs.
- Maintain awareness of new developments in Medical Writing and in the global regulatory environment which may be applied to the management and reporting of clinical trial data.
- Provide input into budgetary requirements, perform ongoing financial review of projects, ensure that all issues are highlighted and resolved as quickly as possible and that all non-contract tasks are identified, tracked and included in change order forms.
- Provide input into salary reviews for direct reports and nominate for promotion when ready.
- Ensure all Medical Writing activities are carried out in accordance with Covance or project specific processes.
- Ensure the quality work of the group and department through ongoing quality management and review to ensure high quality deliverables to clients and internal customers.
- Establish and maintain strategic client relationships and receive client satisfaction surveys. Support corporate business development and marketing activities at client presentations and professional seminars.
- Manage billability of Medical Writing staff.
- Ensure that revenue and operating margin meet agreed targets.
- Ensure that the staff are utilized as fully, but also as efficiently as possible. Ensure that resource information is applied across projects to increase utilization, improve efficiency or amend the resource levels required on a project as necessary.
- Support writing teams in the planning and execution of major regulatory submissions (e.g., MAA, CTD).
- To deputize for the Head of the group
Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred
- Typically minimum 10 years medical writing experience
- Excellent people management skills and supervisory skills gained from a minimum of 5years line management experience.
- Knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
- Excellent oral and written communication and presentation skills
- Self-motivated to work consistently in a fast-paced, rapidly changing environment
- Logical thinking, attention to detail