Senior Medical Writer - FSP

• Serve as an integrated member of the team, delivering medical writing services for the development of clinical documents
• Participate in ongoing project-related activities, such as planning, project discussions, and all required training sessions
• Document management:
  Set-up and management of clinical document in the Electronic Document Management System (EDMS)
• Review and approval of the Statistical Analysis Plan in the EDMS
• Management of timelines including proposal of timelines to trial/project team
• Preparation for and attendance of the required trial team meetings or submission meetings
• Writing of drafts including appropriate in-text tables and figures according to the timelines agreed upon with trial/project team
• Provision of drafts and management of all review cycles by the trial/project team, reaching consensus on comments/changes
• Initiation and monitoring or conducting of Quality Control (QC) checks as well as completion of the Quality Control Documentation Form (QCDF)
• Creation and provision of the final document version to the trial/project team
• E-approval of final clinical document in the EDMS

• Bachelor's degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
• Approx 5 years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered
• Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
• Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements
• Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams
• Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
• Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
• Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed
• High attention to detail with a commitment to quality, consistency, and scientific accuracy
• Proficiency in Microsoft Word and document formatting best practices
• Experience with electronic document management systems (eDMS) and familiarity with document templates, style guides, and structured authoring tools.

Demonstrates expertise in medical writing for clinical documents, with strong knowledge of global regulatory requirements and clinical research processes. Proven ability to manage timelines, collaborate with cross-functional teams, and ensure quality and accuracy in document preparation.

• Medical Writing
• Regulatory Requirements
• Project Management
• Clinical Research Processes
• Electronic Document Management Systems

• Medical Writing
• Regulatory Submission
• Statistical Analysis Plan Review
• Quality Control Checks
• Document Management
• Data Analysis
• Study Design
• Document Formatting
• Draft Preparation
• Consensus Building

• Excellent Communication Skills
• Organizational Skills
• Time Management
• Attention to Detail
• Collaborative Teamwork

• Biopharmaceutical
• Biotechnology
• CRO
• ICH Guidelines
• FDA Regulations
• EMA Guidelines

• Microsoft Word
• Electronic Document Management Systems
• Structured Authoring Tools