Senior Associate Scientist, Scientific Writing
Forge Biologics•Columbus, OH
•Onsite
About The Position
The Senior Associate Scientist, Scientific Writing 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
Benefits
- Health, dental, and vision insurance start your first day — with 90% of premiums covered for you and your family.
- A competitive paid time off plan
- 12 weeks of fully paid parental leave
- Annual bonus opportunities for all full-time team members.
- 401(k) with company match
- Special employee discounts, including childcare and dependent care savings.
- Onsite fitness facility at The Hearth
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short- and long-term disability coverage
- A fully stocked kitchen with free snacks and beverages
- Ongoing professional development resources, training opportunities, and mentorship programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
