Associate Director, X-ta Regulatory Medical Writing

Johnson & Johnson Johnson & Johnson · Pharma · Beerse, Antwerp, Belgium +1

Associate Director, Regulatory Medical Writing role at Johnson & Johnson, focusing on preparing and finalizing clinical documents for therapeutic areas. Requires leadership in writing teams, process improvement, and people management within a regulated pharmaceutical environment.

What you'd actually do

  1. Leading compound/submission/indication/disease area writing teams independently.
  2. Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
  3. Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
  4. Manage direct reports in Medical Writing.
  5. Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.

Skills

Required

  • University/college degree in a scientific discipline
  • 10 years of relevant pharmaceutical/scientific experience
  • 8 years of relevant Medical Writing experience
  • 2 years of people management experience
  • Strong attention to detail
  • Strong oral and written communication skills
  • Fluent written and spoken English
  • Expert project management skills
  • Expert project/process improvement leadership
  • Expert leadership skills
  • Strong people management skills
  • Ability to delegate responsibility to junior writers
  • Ability to recognize how to best interpret, summarize, and present statistical and medical information

Nice to have

  • Masters or PhD preferred
  • Multiple therapeutic area experience preferred

What the JD emphasized

  • At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
  • At least 2 years of people management experience.