Medical Writer III, Oncology

Johnson & Johnson

. Write or coordinate clinical and regulatory documents, including CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents .

Posted 10/16/2026full-timeUnited StatesMid-LevelSenior💰 $109,000 - $174,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory medical writing, including the creation and coordination of clinical documents such as CSRs and protocols. Proven ability to lead cross-functional teams, mentor junior staff, and manage complex projects within the pharmaceutical industry.

Highest-signal resume keywords

Regulatory Medical Writing ExperienceClinical Document CoordinationLeadership Skills in Project ManagementOncology Therapeutic Area ExperienceAdvanced Degree (Masters, PhD, MD)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Reports (CSRs)Investigational Brochures (IBs)Regulatory Submission DocumentsStatistical Information InterpretationDocument Planning and ReviewProject TrackingMetrics Database ManagementTime ReportingMedical Writing Best PracticesCompound Lead Experience

Soft Skills

Collaboration with Cross-Functional TeamsMentoring CompetencyAttention to DetailProblem-Solving AbilityRelationship Building

Industry Keywords

Pharmaceutical Industry ExperienceScientific Discipline DegreeGlobal Team CollaborationFlexibility in Daily RoutineProcess Working Groups

About the role

Key responsibilities & impact

Write or coordinate clinical and regulatory documents, including CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents
Lead cross-functional document planning and review meetings
Interact with clinical, regulatory, biostatistical, and other cross-functional colleagues on document content
Champion medical writing processes and best practices
Establish document timelines and strategies in accordance with internal processes
Complete time reporting, training, metrics database, and project tracking updates
Function as lead writer on most compounds, submissions, indications, or disease areas under supervision
Serve as primary medical writing contact for cross-functional teams
Coach or mentor junior staff on document planning, processes, and content
Provide peer review as needed
Participate in or lead process working groups
Collaborate with external service providers and partner company staff as needed

Requirements

What you’ll need

University/college degree in a scientific discipline required
At least 6 years of relevant pharmaceutical/scientific industry experience
At least 4 years of regulatory medical writing experience
Proficiency in written and spoken English
Ability to interpret, summarize, and present statistical and medical information accurately in complex document types
Ability to collaborate with global teams and stakeholders across time zones, with flexibility in daily routine
Ability to build positive relationships with cross-functional team members
Strong leadership skills in project, process, and time management
Ability to resolve complex problems under supervision
Learning agility and mentoring competency
Strong attention to detail
Oncology therapeutic area experience preferred
Advanced degree (Masters, PhD, MD) preferred
Compound lead and/or submission lead experience preferred

Benefits

Comp & perks

Annual performance bonus eligibility
Medical, dental, and vision insurance
Life insurance
Short- and long-term disability insurance
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation up to 120 hours per calendar year
Sick time up to 40 hours per calendar year
Holiday pay, including floating holidays, up to 13 days per calendar year
Work, Personal and Family Time up to 40 hours per calendar year
Hybrid work arrangement with 3 days onsite weekly
Remote work options may be considered case-by-case if approved