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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in preparing clinical regulatory documents and public-facing materials while applying critical thinking and problem-solving skills. Capable of leading teams, managing projects, and mentoring less experienced writers in a deadline-driven environment.
Highest-signal resume keywords
Clinical Regulatory Document PreparationMedical Writing Project ManagementTeam Leadership in Medical WritingCritical Thinking and Problem-SolvingMicrosoft Office Suite Proficiency
About the role
Key responsibilities & impact- Prepare clinical regulatory documents, including protocols, clinical study reports, participant narratives, and investigator’s brochures
- Prepare public-facing documents, including informed consent forms, clinical trial registration and results postings, and plain language summaries
- Design, plan, author, edit, and review accurate, clear, high-quality documents
- Contribute scientifically and collaborate on document-specific cross-functional teams
- Apply critical thinking, problem-solving, and negotiation skills to address challenges across documents, content, processes, timelines, and tools
- Keep medical writing project leads and/or management informed and escalate issues affecting timelines, quality, or compliance
- Use medical writing-specific tools and technology platforms
- Participate in or lead initiatives improving medical writing processes and standards
- Apply knowledge of clinical development, regulations, disease areas, and company products
- Help orient new team members and mentor less experienced writers
- Potentially manage direct reports, including workload, professional development, and performance management
Requirements
What you’ll need- Bachelor’s degree preferably in a health, scientific, or relevant discipline
- 3+ years of relevant medical writing or industry experience
- Experience managing multiple writing projects in a deadline-driven environment
- Experience leading teams of medical writers and/or cross-functional team members
- Ability to interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines, with minimal supervision
- Demonstrated critical thinking and problem-solving capabilities
- Experience with conflict resolution and negotiation in cross-functional teams
- Ability to adapt to changing project needs and unexpected workload demands
- Strong oral and written communication and presentation skills
- Technical expertise in Microsoft Office Suite and shared document systems such as SharePoint
- Willingness to learn and adapt to emerging technology
- Experience independently preparing clinical regulatory documents in accordance with regulatory requirements and industry guidelines
- Must be a US or Puerto Rico resident
- No visa sponsorship available
- Travel requirements: 10%
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study Report PreparationProtocol DevelopmentInformed Consent Form CreationPlain Language SummariesDocument Editing and ReviewClinical Data InterpretationConflict ResolutionNegotiation SkillsRegulatory ComplianceEmerging Technology Adaptation
Soft Skills
Strong Oral CommunicationStrong Written CommunicationPresentation SkillsCollaborationMentoring
Tools & Technologies
Medical Writing ToolsSharePointDocument Management Systems
Industry Keywords
Clinical DevelopmentRegulatory RequirementsIndustry GuidelinesHealth SciencesScientific Discipline