Senior Director, Medical Writing

Found in: Appcast Linkedin GBL C2 - 3 weeks ago

England, United Kingdom Grace Fredricks Recruitment Full time

Role: Senior Director, Regulatory Medical Writing

Location: Europe

Travel: Homebased


Position Summary:

  • Leads in a team environment and matrix.
  • Contributes to and champions internal standards, regulatory, and publishing guidelines.
  • Contributes to and champions the improvement of internal systems, tools, and processes.
  • Able to prepare complex documents within and across therapeutic areas (TAs) (see examples under "principal responsibilities") independently.
  • Leads in setting functional tactics/strategy.
  • Leads TA-level strategy (e.g., submission team, global program team, clinical team).
  • Able to oversee the work of external contractors. Can represent TA head at high-level and cross functional TA meetings and has some independent decision-making authority.


If a people manager:

  • Manage a team of internal medical writers (direct reports).
  • Accountable for compliance aspects of direct reports' work.
  • Mead lead in resource management and actively participate in hiring decisions.


Principal Responsibilities:

  • Prepares and finalizes all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.
  • Leads in a team environment. Works with a high-level of independence and takes a lead role on assigned projects with respect to timing, scheduling, and tracking.
  • Directly leads or sets objectives for others on team projects and tasks, e.g., able to lead process working groups or Communities of Practice.
  • Guides or trains cross-functional team members on processes, best practices; coach or mentor more junior writers.
  • Able to lead compound/submission/indication/DAS writing teams independently.
  • Proactively identifies and champions departmental process improvements.


Principal Relationships:

  • Functional Contacts Inside the Company (as collaborator and peer): Reg MW leadership team, manager, peer writers. Employees from other departments.
  • Contacts Outside the Company: May oversee day-to-day project-related work of contractors or external service providers as needed. May collaborate with external partner company staff on codeveloped compounds.
  • Supervision (direct): Direct reports (if applicable), and others as assigned.


Education and Experience Requirements:

  • A university/college degree is required plus at least 12 years in relevant pharmaceutical/scientific experience. An advanced degree (eg, Masters, PhD, MD) is preferred.
  • At least 10 years of relevant medical writing experience is required.
  • At least 2 years of people management experience if a people manager.
  • Experience in project management and process improvement is required.

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