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Posted: 10/19/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in Medical Writing, including the preparation of clinical protocols and regulatory documents, while ensuring compliance with GCP, ICH, and eCTD standards. Proven ability to collaborate cross-functionally and mentor team members to enhance writing capabilities and meet organizational objectives.
Highest-signal resume keywords
Medical WritingRegulatory Document PreparationKnowledge of GCP/ICH/eCTDProject ManagementCross-Functional Collaboration
About the role
Key responsibilities & impact- Independently plan, develop, and deliver high-quality, strategically aligned clinical and regulatory documents
- Plan, prepare, write, edit, format, and finalize clinical protocols, clinical study reports, Investigator’s brochures, Module 2 summaries, annual regulatory submission updates, briefing books, and regulatory responses
- Provide product and platform writing and strategy support to cross-functional teams
- Represent Medical Writing on project teams and advise on content and format requirements
- Coordinate writing activities, timelines, and review/revision responsibilities
- Ensure adherence to Medical Writing processes and compliance with global regulations
- Collaborate cross-functionally to drive best practices, implement lessons learned, and improve capabilities
- Maintain knowledge of regulations, product areas, current trends, and literature
- Create and maintain SOPs and other Medical Writing governance documents
- Identify and solve compliance or efficiency gaps in processes
- Participate in meetings supporting alignment between electronic document, quality, and TMF systems
- Provide Medical Writing performance metrics and take corrective action as needed
- Participate as a member of Global Regulatory, Clinical Trial, and other product teams
- Support development, onboarding, and training for direct reports and the Medical Writing team
- Mentor colleagues as needed
- Support corporate objectives and organizational business objectives
- Escalate and communicate issues to supervisors and Medical Writing stakeholders
Requirements
What you’ll need- Bachelor’s degree or equivalent; life sciences is preferred
- 10+ years of relevant experience, with 8+ years of medical writing or other writing experience
- Excellent writing skills
- Ability to understand, interpret, and communicate clinical and scientific data
- Knowledge of drug development process
- Knowledge of current regulatory requirements and guidelines applicable to GCP/ICH/eCTD compliant documents
- Previous experience with NDAs/BLAs with active contribution in preparation and writing of clinical and regulatory documents is required
- Proven ability to multitask, deal with competing priorities, and meet aggressive timeline expectations
- Experience and success in working with cross-functional teams
- Excellent interpersonal and communication skills
- Proven flexibility/adaptability to work in a fast-paced and dynamic environment
- Knowledge and application of Good Clinical Practice, Good Documentation Practices, International Council for Harmonization E6(R2), and ALCOA+ standard
- Track record for building excellent constructive, positive, collaborative relationships
- Demonstrated project management experience
- Advanced proficiency in MS Office Suite and ability to quickly learn new electronic applications
- Must be authorized to work in the U.S.
Benefits
Comp & perks- Physical and Emotional Wellness resources
- Financial Wellness resources
- Support for Caregivers
- Comprehensive benefits package
- Competitive compensation and benefit package
- Work-life resources
- Company-sponsored in-person events
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 Protocol WritingClinical Study Report WritingInvestigator’s Brochure PreparationRegulatory Submission UpdatesSOP CreationData InterpretationDocument FormattingPerformance Metrics AnalysisMultitaskingDrug Development Knowledge
Soft Skills
Excellent Writing SkillsInterpersonal SkillsCommunication SkillsFlexibility/AdaptabilityRelationship Building
Tools & Technologies
MS Office SuiteElectronic Document SystemsQuality Management SystemsTMF Systems
Industry Keywords
Clinical TrialsGood Clinical PracticeGood Documentation PracticesInternational Council for HarmonizationNDABLA