Medical Writer II, Oncology

Johnson & Johnson

. Author and coordinate regulatory medical writing documents for the Oncology therapeutic area .

Posted 10/5/2026full-timeUnited StatesJuniorMid-Level💰 $92,000 - $148,350 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory medical writing within the Oncology therapeutic area, including the ability to author and coordinate complex documents such as protocols and clinical study reports. Possesses strong project management skills and the ability to collaborate effectively with cross-functional teams while adhering to regulatory guidelines.

Highest-signal resume keywords

Regulatory Medical WritingProject ManagementStrong Communication SkillsKnowledge of ICH RequirementsMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Medical WritingPhase 1 ProtocolsPhase 2/3 CSRsDocument Quality ControlLiterature SearchesStatistical Data InterpretationProject TrackingSOP AdherenceMedical Writing Style GuideAbbreviation and Reference Lists

Soft Skills

Team CollaborationProblem-SolvingAttention to DetailTime ManagementEmerging Leadership

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

OncologyPharmaceuticalScientific ExperienceRegulatory GuidelinesCross-Functional Collaboration

About the role

Key responsibilities & impact

Author and coordinate regulatory medical writing documents for the Oncology therapeutic area
Write and coordinate Phase 1 protocols, Phase 1/2 CSRs, study tables, narratives, and initial IBs
Write, contribute to, and coordinate Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses
Perform document quality control and complete abbreviation and reference lists
Conduct literature searches and other basic medical writing tasks
Participate in and lead cross-functional document planning and review meetings
Manage project timing, scheduling, tracking, document timelines, and strategies
Collaborate with clinical, regulatory, biostatistical, and other cross-functional colleagues
Guide or train cross-functional team members on processes and best practices
Lead early- or late-stage compound writing teams with supervision
Follow SOPs, templates, best practices, policies, and the Medical Writing Style Guide
Attend departmental and cross-functional meetings
Complete time reporting, training, metrics database, and project tracking updates
Maintain knowledge of industry, company, and regulatory guidelines
Mentor junior staff and provide peer review
Interact with or oversee contractors and external service providers under supervision

Requirements

What you’ll need

A university/college degree in a scientific discipline is required
At least 2 years of relevant pharmaceutical/scientific experience
2 to 4+ years of regulatory medical writing experience
Strong oral and written communication skills in English
Ability to understand, interpret, and summarize scientific or medical data
Ability to function in a team environment and build positive cross-functional relationships
Demonstrated problem-solving skills
Strong attention to detail
Strong time management and project/process management skills
Learning agility in interpreting, summarizing, and presenting statistical and medical information
Emerging leadership skills in project, process, and time management
Knowledge of regulatory guidance documents such as ICH requirements
Sound knowledge of Microsoft Word, Excel, PowerPoint, and Outlook

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
Pension plan
401(k) savings plan
Long-term incentive program
Vacation: 120 hours per calendar year
Sick time: 40 hours per calendar year
Holiday pay, including floating holidays: 13 days per calendar year
Work, Personal and Family Time: up to 40 hours per calendar year
Parental Leave: 480 hours within one year of birth/adoption/foster care of a child
Bereavement Leave
Caregiver Leave: 80 hours in a 52-week rolling period
Volunteer Leave: 32 hours per calendar year
Military Spouse Time-Off: 80 hours per calendar year