Principal/Senior Medical Writer - Clinical Document Writing

• Lead the clear and accurate completion of medical writing deliverables
• Manage medical writing activities associated with individual studies and coordinate activities across departments
• Lead resolution of client comments
• Complete clinical and regulatory documents, including protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations
• Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style guides
• Coordinate quality and editorial reviews
• Manage source documentation appropriately
• Lead team document reviews and act as a peer reviewer
• Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency
• Collaborate with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions to issues, escalating as appropriate
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standard practices, and capabilities
• Mentor and lead less experienced medical writers on complex projects
• Develop expertise in industry topics and regulatory requirements affecting medical writing
• Work within budgeted hours and communicate status and changes to medical writing leadership
• Complete required administrative tasks and other assigned duties

Requirements

• Proven strong clinical document writing experience
• Ability to clearly and accurately present scientific information
• Ability to manage medical writing activities with minimal supervision
• Knowledge of regulatory standards, including ICH E3 guidelines
• Ability to follow company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
• Ability to coordinate quality and editorial reviews
• Ability to review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency
• Ability to collaborate with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs
• Experience performing online clinical literature searches and complying with copyright requirements
• Ability to provide technical support, training, and consultation
• Ability to mentor and lead less experienced medical writers on complex projects
• Knowledge of industry topics and regulatory requirements affecting medical writing
• Ability to work within budgeted hours and communicate project status and changes
• Equivalent experience, skills, and/or education will also be considered

Core Competencies

Demonstrates expertise in clinical document writing and regulatory standards, including ICH E3 guidelines, while effectively managing medical writing activities and collaborating with cross-functional teams. Capable of mentoring less experienced writers and ensuring adherence to quality and editorial reviews.

Highest-signal resume keywords

• Clinical Document Writing
• ICH E3 Guidelines
• Regulatory Standards
• Statistical Analysis Review
• Cross-Functional Collaboration

ATS Optimization Keywords Hard Skills

• Medical Writing Deliverables
• Clinical Study Reports
• Protocols
• Informed Consents
• Safety Reports
• IND Submissions
• NDA Submissions
• ECTD Submissions
• Technical Support
• Online Clinical Literature Searches

Soft Skills

• Clear Presentation of Scientific Information
• Mentoring
• Problem Solving
• Communication

Industry Keywords

• Quality Reviews
• Editorial Reviews
• Copyright Compliance
• Authors Requirements
• Budget Management