Medical Writer II, X-TA

Overview

In this role you will contribute to regulatory medical writing across therapeutic areas, shaping clinical documents from early to late-stage trials. You will work in a cross-functional team to apply internal standards and regulatory guidelines, growing into lead writing on projects. You’ll develop and coordinate documents, manage timelines, and mentor junior staff as you help move medicines from lab to life. This hybrid posting offers international exposure and development within a patient-centric, innovation-led company.

Pay / Benefits

• Competitive salary
• Extensive benefits package
• Flexible working environment
• Career development opportunities
• Health and well-being priority
• Inclusive accommodation if needed

Responsibilities

• Write and coordinate basic clinical documents (Phase 1 protocols, Phase 1/2 CSRs, tables, narratives, initial IBs)
• Prepare and coordinate low to medium complexity regulatory documents (Phase 2/3 CSRs, protocols, IB updates, regulatory responses under supervision)
• Perform document QC, reference checks, literature searches, and related basic tasks
• Lead or co-lead cross-functional document planning and review meetings
• Contribute to project timing, scheduling, and tracking; interact with cross-functional colleagues on content
• Establish document timelines and strategies per internal processes with mentorship
• Guide or train team members on processes and best practices as experience grows
• Lead early- or late-stage writing teams with supervision as required
• Adhere to SOPs, templates, and Medical Writing Style Guide; participate in departmental meetings
• Mentor junior staff and provide peer reviews on content and planning
• Maintain knowledge of regulatory guidelines and industry standards
• Complete time reporting, training, and project tracking in relevant systems
• Engage with internal and external stakeholders, including contractors, under supervision

Key requirements

• University/college degree in a scientific discipline
• 2+ years of pharmaceutical/scientific experience
• 2–4+ years of regulatory medical writing experience
• Strong English writing and communication skills
• Ability to interpret, summarize, and present scientific data
• Team-oriented with cross-functional collaboration skills
• Problem-solving ability, attention to detail, and time management
• Learning agility and evolving leadership capabilities
• Knowledge of regulatory guidance documents (ICH)
• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook
• Ability to work under supervision with increasing independence
• Exposure to project planning and document strategies

• Cross-functional collaboration
• Clear communication
• Attention to detail
• Regulatory medical writing
• Clinical document development (protocols, CSRs, IBs)
• Literature searches and reference management

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