Principal Medical Writer

Role Overview

• Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents.
• As necessary, may assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission.
• Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area.
• Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation, including international regulatory guidance and requirements for content and format, work requirements (style, electronic integrity, and process), and project
• or therapeutic area-specific guidance related to content and organization of specific documents.
• Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
• Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications.
• Provides review and substantive editing of contributions, and ensures resolution of issues.
• Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Sponsor requirements and processes across development programs.
• Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
• Acts as a key Medical Point of contact for clinical regulatory strategy.
• As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
• Provides leadership on functional teams that address requirements or issues related to document preparation and production.

Requirements

• Bachelor’s degree in science, health profession required
• At least 5 years of experience writing for pharma or biotechnology preferred.
• 3+ years of electronic documents and submissions required.
• Experience with writing key documents included in major international regulatory submissions required like Clinical study reports, IBs, Protocols
• Experience managing writing activities for a major international regulatory submission preferred.
• Knowledge and Skills: Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
• Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production (including CTDs).
• Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
• Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.