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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing, including the ability to develop and review clinical and regulatory documents while applying critical thinking and problem-solving skills. Proven leadership in managing writing projects and mentoring teams within a compliance-focused environment.
Highest-signal resume keywords
Medical WritingClinical Development KnowledgeProject ManagementLeadership in Cross-Functional TeamsRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical Writing Best PracticesClinical Regulatory Document PreparationCritical Evaluation of Clinical DataLean Writing PrinciplesHealth Literacy Principles
Soft Skills
Critical ThinkingProblem-SolvingNegotiation SkillsEffective LeadershipConflict Resolution
Tools & Technologies
Microsoft Office SuiteSharePointMedical Writing-Specific Tools
Industry Keywords
Clinical DevelopmentRegulatory RequirementsIndustry GuidelinesTherapeutic AreasScientific Expertise
About the role
Key responsibilities & impact- Develop, author, edit, and lead the review of accurate, clear, and compliant clinical, regulatory, and/or public-facing documents
- Partner with project leads to support multiple programs and therapeutic areas across the company portfolio
- Apply medical writing best practices, including lean writing and health literacy principles
- Contribute scientific expertise and collaborate on cross-functional teams
- Apply critical thinking, problem-solving, and negotiation skills to complex medical writing challenges
- Provide program oversight and keep project leads and/or management informed of issues affecting timelines, quality, or compliance
- Use medical writing-specific tools and technology platforms
- Lead initiatives to improve medical writing processes and standards
- Apply knowledge of clinical development, relevant regulations, disease areas, and company products
- Provide scientific and operational mentorship, coaching, and/or project oversight to other medical writers
- May manage direct reports, including workload, professional development, and performance management
Requirements
What you’ll need- Bachelor’s degree or higher, preferably in a health, scientific, or relevant discipline
- 5+ years of relevant medical writing or industry experience
- Experience managing complex writing projects in a deadline-driven environment
- Experience leading teams of medical writers and/or cross-functional team members
- Ability to critically evaluate and interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines
- Critical thinking and problem-solving capabilities
- Ability to innovate, influence, and drive change
- Effective leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision making
- Excellent 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 preferred
- No visa sponsorship
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
- Relocation: No relocation
- 10% travel requirements
