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Medical Writer II
Johnson & Johnson. Support one or more therapeutic areas within the Regulatory Medical Writing team .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory medical writing, including the ability to author and coordinate clinical documents such as CSRs and protocols. Possesses strong communication, project management, and leadership skills to effectively collaborate with cross-functional teams and mentor junior staff.
Highest-signal resume keywords
Regulatory Medical WritingClinical Document AuthoringProject ManagementStrong 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 Document WritingClinical Study Reports (CSRs)Protocol DevelopmentLiterature SearchDocument Quality ControlStatistical Data InterpretationTime ManagementProcess ManagementMentoringSOP Adherence
Soft Skills
Team CollaborationProblem-SolvingAttention to DetailLearning AgilityCross-Functional Relationship Building
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook
Industry Keywords
Pharmaceutical ExperienceScientific DisciplineRegulatory GuidelinesMedical Writing Style Guide
About the role
Key responsibilities & impact- Support one or more therapeutic areas within the Regulatory Medical Writing team
- Author diverse regulatory medical writing documents
- Write 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, compile abbreviations and references, conduct literature searches, and complete other basic tasks
- Participate in and potentially lead cross-functional document planning and review meetings
- Take an active role in project timing, scheduling, and tracking
- Interact with cross-functional colleagues on document content and champion medical writing processes and best practices
- Establish document timelines and strategies in accordance with internal processes
- Guide or train cross-functional team members on processes and best practices as experience increases
- Lead early- or late-stage compound writing teams with supervision as required
- Learn and adhere to 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 and apply knowledge of industry, company, and regulatory guidelines
- Mentor junior staff on document planning, processes, content, or peer review
- Interact with or oversee contractors and external service providers under close supervision
Requirements
What you’ll need- A university/college degree in a scientific discipline is required
- Advanced degree such as a 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
- Demonstrated 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- An annual bonus with set target depending on pay grade/location, based on employee and company performance, or sales commissions
- 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
- Participation in several insurance plans for employees and eligible dependents in some locations
- Reasonable accommodation for applicants and employees with disabilities