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Medical Writer III
Johnson & JohnsonMedical Writer III responsible for writing and coordinating clinical and regulatory documents for healthcare innovations. Leading document planning and collaborating with cross-functional teams across therapeutic areas.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory medical writing, including the preparation of clinical and regulatory documents, while effectively leading cross-functional teams and mentoring junior staff. Proficient in managing document timelines and strategies within the pharmaceutical industry, particularly in the immunology therapeutic area.
Highest-signal resume keywords
Regulatory Medical WritingClinical Study Reports (CSRs)Immunology Therapeutic Area ExperienceDocument Planning and ReviewAttention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Study Reports (CSRs)Investigational Brochures (IBs)Regulatory ResponsesProtocolsRisk Management Plans (RMPs)Briefing DocumentsDocument Timeline ManagementProject TrackingMetrics Database ManagementScientific Writing
Soft Skills
CoachingMentoringCross-Functional CollaborationCommunication
Certifications & Qualifications
Advanced Degree (Masters, PhD, MD)
Industry Keywords
Pharmaceutical IndustryRegulatory AffairsScientific DisciplineProcess Working Groups
About the role
Key responsibilities & impact- Writing or coordinating clinical and regulatory documents such as CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents
- Leading cross-functional document planning and review meetings
- Interacting with cross-functional colleagues on document content
- Responsible for establishing document timelines and strategies
- Completing all time reporting, training, metrics database, and project tracking updates
- Acting as primary point of contact for medical writing activities for the cross-functional team
- Coaching or mentoring more junior staff
- Actively participating in or leading process working groups
Requirements
What you’ll need- Minimum of university/college degree in a scientific discipline is required
- An advanced degree (eg, Masters, PhD, MD) is preferred
- At least 6 years of relevant pharmaceutical/scientific industry experience
- At least 4 years of regulatory medical writing experience
- Immunology therapeutic area experience is strongly preferred
- Proficiency in written and spoken English is essential
- Strong attention to detail
Benefits
Comp & perks- an annual bonus with set target (% of pay)
- vacation days
- parental leave for a minimum of 12 weeks
- bereavement leave
- caregiver leave
- volunteer leave
- well-being reimbursement
- programs for financial, physical and mental health
- service anniversary and recognition awards
- eligibility for several insurance plans