Senior Associate Scientist, Scientific Writing

Forge Biologics의 Senior Associate Scientist, Scientific Writing 직무 입사 지원서 • Columbus, OH

14d

About The Position

About The Role: The Senior Associate Scientific Writer independently leads documentation projects across operational, analytical, microbiological, and stability functions within QC. This role requires deeper collaboration with subject matter experts across all departments and QC team members of all levels.

Requirements

• Bachelor’s degree in a science field with 2-3 years of experience, or Master’s in a science field with writing experience
• Demonstrated leadership, strategic thinking
• Proven ability to manage ambiguity, lead complex projects, and influence cross-functional teams
• Experience authoring complex technical documents
• Knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, cell-based infectivity assays, potency assays)
• Experience in scientific communication
• Skilled in managing multiple document types and priorities simultaneously
• Excellent written, verbal, and project coordination skills
• High proficiency in documentation systems, formatting tools, and visualization software

Nice To Haves

• Previous exposure regulatory guidelines (ICH, FDA, EMA)
• Experience mentoring or training junior teammates
• Proficiency with Smartsheet, Veeva Vault, SmartDraw, Visio, Adobe Acrobat, or similar tools
• Expertise in software tools such as Veeva Vault, SmartDraw, Visio, and Adobe Acrobat
• Strategic thinking with a continuous improvement mindset related to document systems and compliance

Responsibilities

• Works with cross-functional teams with guidance from direct supervisor and senior team members to develop and maintain high-level technical and scientific documents, including Standard operating procedures for the QC group
• Protocols and reports using established templates
• Owns and manages documentation projects by participating in cross-departmental conversations to ensure alignment with QC requirements
• Assists SMEs and development teams through updates driven by method qualification, continuous improvement, or change controls
• Assists junior QC associates in writing standards
• Reviews documentation for quality, and ensures alignment across client deliverables
• Collaborates with SMEs to identify gaps in documentation and fill those gaps with clear, accurate information
• Organize information from multiple sources impacting documentation
• Demonstrates fluency in Veeva Vault and communicates with system owners to ensure process continuity

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees