Director, Medical Writing, Late Phase

November 3, 2022
United States
Job Type
Work Setting


The Director of Medical Writing Late Phase will have management of both direct and indirect reports. Management and development of Medical Writing staff. Development and oversight of processes to produce high-quality documents. Resourcing Medical Writing projects and ensuring timely completion of Medical Writing projects. Client and business development activities.

What to Expect

  • 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 an ongoing financial review of projects, and 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 on targets.
  • Ensure that the staff is 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

Education / Qualifications

  • Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., Ph.D. or Masters) preferred


  • Typically a minimum of 10 years of medical writing experience
  • Excellent people management skills and supervisory skills gained from a minimum of 5 years of 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
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Resume, cover letter, or other documents as required per the job description

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