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Medical Writer II, Oncology
Johnson & Johnson. Author and coordinate basic clinical documents, including Phase 1 protocols, Phase 1/2 CSRs, tables of studies, narratives, and initial IBs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory medical writing, including the creation and coordination of clinical 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 ManagementClinical Document CoordinationStrong Communication SkillsKnowledge of ICH Requirements
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Medical WritingClinical Document PreparationQuality ControlLiterature SearchData InterpretationStatistical SummaryProject TrackingDocument Timeline ManagementSOP AdherenceMedical Writing Style Guide
Soft Skills
Team CollaborationProblem-SolvingAttention to DetailLearning AgilityEmerging Leadership
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook
Industry Keywords
Clinical TrialsPharmaceutical ExperienceRegulatory GuidelinesCross-Functional CollaborationMedical Writing Best Practices
About the role
Key responsibilities & impact- Author and coordinate basic clinical documents, including Phase 1 protocols, Phase 1/2 CSRs, tables of studies, narratives, and initial IBs
- Write, contribute to, and coordinate low- to medium-complexity clinical and regulatory documents, including Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses
- Perform document quality control, prepare abbreviation/reference lists, conduct literature searches, and complete other basic medical-writing tasks
- Participate in and potentially 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
- Champion medical-writing processes and best practices
- Guide or train cross-functional team members as experience develops
- Lead early- or late-stage compound writing teams under supervision
- Adhere to SOPs, templates, policies, best practices, 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 as needed
Requirements
What you’ll need- University/college degree in a scientific discipline required
- Advanced degree (Master’s degree, PhD, or MD) preferred
- At least 2 years of relevant pharmaceutical/scientific experience required
- 2 to 4+ years of regulatory medical writing experience required
- 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 and ability to interpret, summarize, and present statistical and medical information under supervision
- 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 bonus with set target depending on pay grade/location, based on employee and company performance
- Sales commissions
- Vacation days
- Parental leave for a minimum of 12 weeks
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Well-being reimbursement
- Programs supporting financial, physical, and mental health
- Service anniversary and recognition awards
- Insurance plans for employees and eligible dependents in some locations
- Reasonable accommodation for applicants and employees with disabilities