Preparing and finalizing all types of clinical documents
Leading in a team environment
Working with a high level of independence and taking a lead role on assigned projects
Leading or setting objectives for others on team projects and tasks
Guiding or training cross-functional team members on processes and best practices
Potentially leading project-level/submission/indication writing teams
Proactively providing recommendations for departmental process improvements
Responsible for planning and leading the writing group for assigned program
Actively participating in medical writing and cross-functional meetings
Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed

University/college degree required
Masters or PhD preferred
At least 8 years of relevant pharmaceutical/scientific experience
At least 6 years of relevant medical writing experience is required
Attention to detail
Excellent oral and written communication skills are pivotal to engage in cross-functional discussions
English fluency required
Expert project/time management skills
Strong project/process leadership skills
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content
Able to resolve complex problems independently
Demonstrate learning agility
Able to build and maintain solid and positive relationships with cross‐functional team members
Solid knowledge and application of regulatory guidance documents such as ICH requirements

Manager, Regulatory Medical Writing

Key skills