Medical Writer II, Oncology

Jobtailor; Beerse; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Jobtailor is seeking a Regulatory Medical Writer with 2+ years of pharmaceutical writing experience to support Oncology projects. You will author and coordinate Phase 1/2/3 documents, manage timelines, and collaborate with cross-functional teams in a dynamic setting.

The role emphasizes adherence to SOPs, mentoring junior staff, and maintaining industry knowledge. Strong English communication and data interpretation skills are essential.

Qualifications

• A university/college degree in a scientific discipline is the minimum requirement.
• Advanced degree (Master’s degree, PhD, MD) preferred.
• At least 2 years of pharmaceutical/scientific experience required.
• 2 to 4+ years of regulatory medical writing experience required.
• Strong oral and written communication skills in English.
• Ability to understand, interpret, and summarize scientific or medical data.
• Ability to function in a team environment and build positive relationships with cross-functional team members.
• Demonstrated problem-solving skills.
• Strong attention to detail.
• Strong time management and project/process management skills.
• Learning agility in interpreting, summarizing, and presenting statistical and medical information.

Responsabilités

• Author and coordinate regulatory medical writing documents supporting Oncology.
• Write and coordinate basic clinical documents, including Phase 1 protocols and Phase 1/2 CSRs, tables of studies, narratives, and initial IBs.
• Write, contribute to, and/or coordinate Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses.
• Perform document QC, complete abbreviation/reference lists, conduct literature searches, and other basic tasks.
• Participate in cross-functional document planning and review meetings; manage timelines.

Connaissances

Regulatory medical writing

Project management

Team collaboration

Attention to detail

Time management

Leadership potential

Formation

Bachelor's degree in a scientific discipline

Advanced degree (Master’s/PhD/MD) preferred

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Description du poste

• Author and coordinate regulatory medical writing documents supporting Oncology
• Write and coordinate basic clinical documents, including Phase 1 protocols, Phase 1/2 CSRs, tables of studies, narratives, and initial IBs
• Write, contribute to, and/or coordinate low- to medium-complexity clinical and regulatory documents, including Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses
• Perform document QC, complete abbreviation/reference lists, conduct literature searches, and perform other basic tasks
• Participate in and potentially lead cross-functional document planning and review meetings
• Manage project timing, scheduling, tracking, document timelines, and strategies
• Collaborate with clinical, regulatory, biostatistical, and other cross-functional colleagues
• Guide or train cross-functional team members on processes and best practices
• Lead early- or late-stage compound writing teams with supervision
• Learn and adhere to SOPs, templates, best practices, policies, and the Medical Writing Style Guide
• Attend departmental and cross-functional meetings
• Complete time reporting, training, metrics database, and project tracking updates
• Maintain knowledge of industry, company, and regulatory guidelines
• Mentor junior staff on document planning, processes, content, or peer review
• Interact with or oversee contractors and external service providers under close supervision

Requirements

• A university/college degree in a scientific discipline is the minimum requirement
• Advanced degree (eg, Master’s degree, PhD, MD) preferred
• At least 2 years of relevant pharmaceutical/scientific experience required
• 2 to 4+ years of regulatory medical writing experience required
• Strong oral and written communication skills in English
• Ability to understand, interpret, and summarize scientific or medical data
• Ability to function in a team environment and build positive relationships with cross-functional team members
• Demonstrated problem-solving skills
• Strong attention to detail
• Strong time management and project/process management skills
• Learning agility in interpreting, summarizing, and presenting statistical and medical information
• Emerging leadership skills in project/process and time management
• Knowledge of regulatory guidance documents such as ICH requirements
• Sound knowledge of Microsoft Office programs (Word, Excel, PowerPoint, Outlook)

Core Competencies

Demonstrates expertise in regulatory medical writing, including the creation and coordination of clinical documents such as protocols and clinical study reports. Possesses strong project management skills and the ability to collaborate effectively with cross-functional teams while adhering to regulatory guidelines.

Highest-signal resume keywords

• Regulatory Medical Writing
• Clinical Document Coordination
• Project Management
• Strong Communication Skills
• Knowledge of ICH Requirements

ATS Optimization Keywords

Hard Skills

• Regulatory Medical Writing
• Clinical Document Writing
• Document Quality Control
• Literature Search
• Data Interpretation
• Statistical Summarization
• Project Tracking
• Document Timeline Management
• Mentoring
• SOP Adherence

Soft Skills

• Team Collaboration
• Problem-Solving
• Attention to Detail
• Time Management
• Learning Agility

Industry Keywords

• Oncology
• Phase 1 Protocols
• Phase 2/3 CSRs
• Regulatory Guidelines
• Cross-Functional Collaboration
• Scientific Discipline
• Pharmaceutical Experience

Tools & Technologies

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft Outlook