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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Medical Writing, including authoring, editing, and regulatory compliance, while effectively leading teams and managing projects to ensure high-quality clinical documents. Proficient in leveraging technology solutions to enhance writing processes and maintain industry standards.
Highest-signal resume keywords
Medical Writing LeadershipClinical Document DevelopmentRegulatory Compliance ExpertiseProject ManagementTechnology Implementation
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 Document EditingRegulatory Guidelines KnowledgeICH GCP UnderstandingDocument Management SystemsAuthoring ToolsEditing PlatformsAutomation WorkflowsQuality ControlPerformance Management
Soft Skills
Organizational SkillsInterpersonal SkillsCommunication Skills
Tools & Technologies
MS WordAdobe AcrobatPowerPointElectronic Document Management SystemsDocument Collaboration Tools
Industry Keywords
Clinical Research ProcessSubmission-Ready DocumentsSOPsStakeholder CommunicationConsultant Management
About the role
Key responsibilities & impact- Provide strategic leadership for Medical Writing authoring, technology, and resourcing across therapeutic areas and compounds
- Establish department writing strategies, guidelines, templates, standard timelines, and SOPs aligned with regulatory requirements and industry standards
- Lead Medical Writing submission, authoring, editing, and document review strategies and standards
- Lead incorporation of authoring tools, editing platforms, automation, document management capabilities, and technology-enabled workflows
- Oversee planning, authoring, review coordination, quality control, editing, finalization, and delivery of submission-ready clinical regulatory documents
- Develop and execute internal staffing, writer/editor allocation, consultant support, and outsourcing strategies
- Track document development, editing workload, submission priorities, and staffing needs; allocate work across staff, consultants, and vendors
- Lead and guide Medical Writing and Editing staff on document strategy, content development, editing standards, review processes, issue resolution, stakeholder communication, and delivery
- Manage and develop staff through performance management, recruiting, coaching, training, reviews, succession planning, and professional development
- Represent Medical Writing at cross-company, compound, and therapeutic area meetings
- Lead and participate in technology adoption, process improvement, standards development, and cross-functional working groups
- Oversee external writers, editors, and writing projects, including vendor selection, onboarding, collaboration management, and performance oversight
- Ensure staff training and compliance with internal Medical Writing, Editing, regulatory, process, and technology requirements
Requirements
What you’ll need- Bachelor's degree (advanced degree preferred)
- Minimum of 17 years of industry experience, including a minimum of 10 years of Medical Writing experience
- Minimum of 7 years of management experience
- Expert knowledge of the clinical research process and regulations/guidelines
- Expert clinical document reading, writing, and editing experience
- Excellent organizational, interpersonal, and communication skills
- Excellent knowledge of MS Word, Adobe Acrobat, PowerPoint, electronic document management systems, authoring and editing platforms, document collaboration tools, automation-enabled workflows, and other technologies used to support clinical regulatory document development
- Demonstrated ability to evaluate, implement, and promote technology solutions that improve Medical Writing and Editing quality, consistency, efficiency, compliance, and scalability
- Ability to lead and manage multiple projects
- Thorough understanding of ICH GCP guidelines
- Ability to work 4 days per week on site
- Ability to travel up to 25% as required
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required