Description

You will drive the development of groundbreaking therapies by crafting high-quality scientific documents and managing external writing partners to ensure excellence in regulatory communications.

Requirements

• •Science/medical degree, ideally M.D., Pharm.D., or Ph.D.
• •Over 5 years hands-on experience
• •Drug development experience, preferably oncology or immunology
• •Scientific or medical writer in pharma/biotech
• •Experience drafting documents for multiple indications
• •Drafting CTPs and CSRs for Phase I-III
• •Drafting IBs, CTD modules, and regulatory reports
• •Editing and reviewing R&D reports
• •Drafting R&D reports from source data
• •Native-level English and advantageous German skills
• •Ability to interpret and summarize scientific results
• •Excellent attention to detail
• •Can-do attitude and workload prioritization skills
• •Advanced interpersonal, coordination, and conflict resolution skills
• •Advanced MS Office, Adobe Acrobat, and DMS skills
• •Knowledge of relevant regulations and technical specifications
• •Knowledge of drug development and stakeholder needs
• •Knowledge of statistics, trial design, and reporting

Tasks

• •Write and edit diverse scientific and regulatory documents
• •Format research and clinical development materials
• •Coordinate document preparation, review, and approval processes
• •Verify scientific content for completeness and consistency
• •Ensure documents comply with established standards
• •Manage external writers and outsourced medical writing services
• •Plan and support Statements of Work for external vendors
• •Train and guide others on writing practices and templates
• •Foster compliance with international pharmaceutical regulations
• •Support the implementation of new tools and SOPs
• •Execute complex medical writing tasks with limited supervision
• •Adapt standard procedures for specialized program requirements

Tools & Technologies