Medical Writer III, Regulatory Medical Writing
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Leiden • Belgium
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About the role
- Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents
- Leading cross-functional (eg, with clinical team) document planning and review meetings
- Interacting with cross-functional colleagues on document content and acting as a champion of medical writing processes and best practices
- Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed
- Will function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision
- Will be primary point of contact for medical writing activities for the cross-functional team (eg, clinical)
- Coach or mentor of more junior staff on document planning, processes, and content
- Provides peer review as needed
- Active participant in or lead of process working groups
Requirements
- A university/college degree in a scientific discipline is required
- An advanced degree (eg, Masters, PhD, MD) preferred
- At least 6 years of relevant pharmaceutical/scientific; at least 4 years of relevant medical writing experience is required
- Excellent oral and written communication skills are pivotal to engage in cross-functional discussions
- English fluency required
- Attention to detail
- Able to function in a team environment
- Strong project/time management skills
- Strong project/process leadership skills
- Able to resolve complex problems under supervision
- Demonstrate learning agility
- Able to build solid and productive relationships with cross-functional team members
Benefits
- competitive salary and extensive benefits package
- flexible working environment as we value work-life balance
- career development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingclinical document writingregulatory document writingprotocol developmentsummary document creationregulatory response draftingbriefing document preparationdocument planningpeer reviewproject management
Soft skills
oral communicationwritten communicationattention to detailteam collaborationproject leadershipproblem-solvingmentoringlearning agilityrelationship buildingcross-functional collaboration
Certifications
advanced degreeMastersPhDMD