Associate Director, Regulatory Medical Writing, Oncology
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Beerse • Belgium
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Job Level
About the role
- Able to function as a lead writer on any compound independently.
- Leads in setting functional tactics/strategy.
- Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
- Establishes and drives document timelines and strategies independently.
- Guides or trains cross-functional team members on processes and best practices; coaches or mentors more junior writers.
- Proactively identifies and champions departmental process improvements.
- May lead discussions in medical writing and cross-functional meetings.
Requirements
- Minimum of 10 years of relevant pharmaceutical/scientific experience is required.
- Minimum of 8 years of relevant clinical/regulatory medical writing experience is required.
- Experience in project management and process improvement is required.
- A minimum of 2 years of people management experience is required.
- Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
- Resolves complex problems independently.
- Advanced knowledge and application of regulatory guidance documents such as ICH requirements.
- Excellent oral and written communication skills.
- Attention to detail.
Benefits
- Inclusive work environment
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical writingregulatory writingproject managementprocess improvementstatistical interpretationmedical information presentationdocument timeline managementICH requirementscontent strategyscientific strategy
Soft Skills
leadershipmentoringcoachingcommunicationattention to detailproblem-solvingcross-functional collaborationproactive identification of improvementsindependent workteam guidance