Associate Director, Medical Writing

Johnson & Johnson   •  

Raritan, NJ

Industry: Healthcare

  •  

11 - 15 years

Posted 26 days ago

This job is no longer available.

  • Prepare high quality clinical documents in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency. You will contribute scientifically and strategically to projects and project teams
  • Lead projects and drive strategies within processing/timeline constraints to meet unusual challenges. Lead submission-level, strategic activities for the writing team
  • Guide or train cross-functional team members, including external contractors, on processes and standard methodologies; coach or mentor more junior writers. You will lead the work of other medical writers, external contractors, and document specialists supporting a project
  • 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, eg, able to lead process working groups or Communities of Practice
  • Proactively identifies and champions departmental process improvements. May develop and present standard methodologies to external audiences. May lead cross-functional/cross-TA, cross-J&J process improvement initiatives
  • If a Lead Writer, principal responsibilities include, but are not limited to primary point of contact for Clinical/Global Program Team for medical writing activities; responsible for functional planning and metrics database updates for assigned program; responsible for cultivating RegMW standard methodologies on assigned program
  • Supervise/manage staff members. Regularly meet with staff to ensure appropriate development plans are made, projects assigned, and issues resolved. May make decisions on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, leads in goal-setting and end of year calibration reviews and performance discussions, and contribute to compensation planning


Qualifications

  • 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 is recommended
  • Experience in project management and process improvement is required

7295190211