Senior Associate Scientific Writer

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. 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 groupProtocols and reports using established templatesOwns and manages documentation projects by participating in cross-departmental conversations to ensure alignment with QC requirementsAssists SMEs and development teams through updates driven by method qualification, continuous improvement, or change controlsAssists junior QC associates in writing standardsReviews documentation for quality, and ensures alignment across client deliverablesCollaborates with SMEs to identify gaps in documentation and fill those gaps with clear, accurate informationOrganize information from multiple sources impacting documentationDemonstrates fluency in Veeva Vault and communicates with system owners to ensure process continuity Qualifications:Bachelor's degree in a science field with 2-3 years of experience, or Master's in a science field with writing experienceDemonstrated leadership, strategic thinkingProven ability to manage ambiguity, lead complex projects, and influence cross-functional teamsExperience authoring complex technical documentsKnowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, cell-based infectivity assays, potency assays)Experience in scientific communicationSkilled in managing multiple document types and priorities simultaneouslyExcellent written, verbal, and project coordination skillsHigh proficiency in documentation systems, formatting tools, and visualization softwarePreferred Skills:Previous exposure regulatory guidelines (ICH, FDA, EMA)Experience mentoring or training junior teammatesProficiency with Smartsheet, Veeva Vault, SmartDraw, Visio, Adobe Acrobat, or similar toolsExpertise in software tools such as Veeva Vault, SmartDraw, Visio, and Adobe AcrobatStrategic thinking with a continuous improvement mindset related to document systems and complianceWork Environment and Physical Demands This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Salary : $19