The Job of a Medical Writing Director

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If you have experience in medical writing, you know that it's a well-established profession in the field of biotechnology. In the past, you might have produced documents that enable biotech companies to keep track of research or receive FDA approval for new processes, devices, or drugs. You may have a journalism degree or even a Ph.D. or M.D. in biological sciences. You work in academia, biotechnology and allied industries, government, journalism, or even as a freelance writer. But if you have at least eight years of experience in clinical writing in addition to an advanced degree and some management experience, then it might be time to consider moving up to Medical Writing Director.

Skills and Qualifications of Medical Writing Directors
  • Bachelors degree, Masters Degree, or Ph.D./M.D. in healthcare, biological sciences, biostatistics, or biology-related fields.

  • A minimum of eight years of medical or clinical writing experience for Ph.D.s/M.D.s. The experience requirement is greater for lower academic degrees.

  • Experience planning, organizing, and writing all aspects of research and clinical product-approval documentation.

  • Experience managing a medical writing team.

  • Familiarity with U.S. and European regulations regarding the approval of research or clinical products and processes.

  • Mastery of medical writing skills and experience managing medical writing projects related to global writing submissions.

  • Excellent management, interpersonal, persuasive, and communication skills.

  • Excellent analytical skills and the ability to independently analyze and interpret novel scientific data.

  • Ability to manage and coordinate complex medical writing projects across multiple departments and phases.

  • Ability to drive and manage global changes in strategy and operations.

  • Expertise in word processing, document management, and publishing software.
Medical Writing Directors' Responsibilities
  • Ensure and provide for global submission planning.

  • Manage submissions for clinical and biotech research products and processes.

  • Share medical writing expertise with clinical writing teams.

  • Provide advice on internal and external standards for production of clinical study documentation.

  • Direct and manage one or more teams of expert clinical or medical writers.

  • Ensure efficient and effective writing and management of all phases of clinical or research study reports and documents.

  • Brief documents, regulatory responses, and regulatory annual reports.

  • Ensure global coordination and effective implementation of clinical submission plans.

  • Collect and supervise information regarding projects.

  • Analyze data to predict workload and resource deployment.

  • Communicate priorities to staff and ensure that resource allocation is aligned according to project priorities.

  • Monitor and manage team performance.

  • Establish and maintain operations support to achieve business goals.

  • Plan and develop communication outputs, including presentation materials and project updates, etc. for third-party stakeholders.

  • Implement resource strategy for meeting program deliverables and timelines.

  • Determine resource requirements and communicate them to senior management.

  • Serve on senior management teams to provide strategic directions for achieving company goals.

  • Create and maintain an environment that promotes people development and process efficiencies.

  • Evaluate organizational performance using internal metrics and external industry benchmarks.
If you have the required qualifications and are ready for the job, you should consider becoming a medical writing director. The position of medical writing director is one of the highest positions in the field, as well as one of the highest paid. If you do not already possess the required skills or qualifications, then now is the time for you to begin acquiring them!
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