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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical development and regulatory processes, with a strong focus on leading medical writing projects and managing cross-functional teams. Proficient in critical thinking, problem-solving, and effective communication to ensure high-quality, compliant documentation.
Highest-signal resume keywords
Medical Writing LeadershipClinical Regulatory ExpertiseProject ManagementCritical ThinkingEffective Communication
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 WritingClinical DevelopmentRegulatory ComplianceData AnalysisDocument AuthoringClinical Trial ProcessesICH Guidance InterpretationConflict ResolutionNegotiationPerformance Management
Soft Skills
Decision-MakingProblem-SolvingMentoringCollaborationAdaptability
Tools & Technologies
Microsoft Office SuiteSharePointMedical Writing ToolsDocument Management Systems
Industry Keywords
Good Clinical PracticePharmaceutical LandscapeEmerging Industry TrendsHealth SciencesScientific Expertise
About the role
Key responsibilities & impact- Lead, envision, and plan Clinical and Regulatory Strategic Communications projects
- Engage strategically with stakeholders across departments, divisions, and the company
- Provide scientific expertise and oversight for clinical regulatory and public-facing documents across programs and therapeutic areas
- Design, plan, author, edit, and review accurate, clear, high-quality regulated documents
- Contribute scientifically and collaborate on cross-functional teams
- Apply critical thinking, problem solving, and negotiation to complex medical writing challenges
- Act as escalation point for issues affecting timelines, quality, or compliance
- Lead initiatives to improve medical writing processes and standards
- Provide strategic direction for Medical Writing tools and technology platforms
- Apply expertise in clinical development, regulations, disease areas, and company products
- Provide insight into pharmaceutical landscape and emerging industry trends
- Mentor, coach, and provide project oversight to medical writers
- 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
- 7+ years relevant medical writing or industry experience
- Experience independently leading, managing, overseeing, and/or authoring complex clinical regulatory and/or public-facing documents
- Ability to critically analyze and present clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines
- Strong decision-making skills
- Experience managing multiple, complex projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members
- Demonstrated critical thinking and problem-solving capabilities
- Demonstrated effective leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision making
- Expert knowledge and thorough understanding of end-to-end drug development, clinical research, and clinical trial processes
- Ability to interpret and apply ICH guidance, including Good Clinical Practice, global and local disclosure laws, and corporate policies
- 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
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 days
- Sick days
- No relocation required