Technical Writer

JOB SUMMARY 
The Technical Writer will manage, support, and oversee the creation, editing, and maintenance of scientific and technical documents used internally and externally at BA Sciences. This role partners with analytical scientists, quality assurance team, and other cross functional teams to translate complex analytical data into accurate, client- and regulator-ready documents that adhere to industry, regulatory, and internal quality standards. The ideal candidate demonstrates strong scientific literacy, excellent writing and editing skills, and deep familiarity with documentation practices in a cGMP environment. 

PRIMARY DUTIES AND RESPONSIBILITIES 

Document Development and Execution: 

• Lead, author, review, and finalize high-quality scientific documentation, including analytical methods, protocols, technical reports, validation reports, and regulatory-ready documents to support client needs.  

• Translate analytical results from instruments such as LC-MS, GC-MS, and ICP-MS into clear, accurate written narratives appropriate for clients, regulatory submission, and internal stakeholder. 

• Collaborates with technical subject matter experts (SMEs) to gather information, interpret complex data, and ensure technical accuracy. 

• Provides assistance in gathering information and preparing scientific presentations and publications as needed. 

Quality and Compliance 

• Ensure all documentation aligns with cGMP, company standard operating procedures (SOPs), internal quality standards, and applicable regulatory guidelines (e.g., FDA, EMA standards)  

• Participate in document review cycles, audits, version control processes, and corrective actions for documentation quality issues. 

• Perform quality control checks for accuracy, grammar, clarity, format, and completeness prior to release of documents. 

Standards, Templates and Process Improvement 

• Develop, maintain, and improve standard document templates, SOPs, corporate style guide, and best practices for technical content. 

• Provide guidance on documentation standards, usability, and compliance expectations across scientific teams. 

• Identify opportunities to streamline documentation processes and improve content quality or consistency.  

Training, Mentoring & Collaboration 

• Train and coach scientists and technical staff in effective scientific writing principles and document preparation. 

• Collaborate with quality assurance, client services, and laboratory teams to facilitate documentation deliverables and timelines. 

• Manage multiple documentation projects or tasks simultaneously with strong prioritization and communication.  

REQUIREMENTS & QUALIFICATIONS 

Education and Experience 

• A master's degree in a scientific discipline or a bachelor's degree in a scientific discipline with at least 2 years of technical writing and editing experience in a regulated or cGMP environment.   

• Proven experience in authoring or contributing to scientific publications, regulatory documents, or laboratory reports.  

Technical Knowledge and Skills 

• Strong understanding of analytical laboratory techniques specifically mass spectrometry techniques, including LC-MS, GC-MS, and ICP-MS. Demonstrated ability to translate scientific data into written narratives that meet regulatory, client, and internal quality requirements. 

• Experience with document control systems and version-controlled documentation processes. 

• Familiarity with industry and regulatory documentation standards, including regulatory submission practices.  

Communication & Collaboration 

• Exceptional written communication and technical editing skills with meticulous attention to detail. 

• Strong collaboration skills, capable of working with cross-functional scientific teams and subject matter experts. 

• Effective coaching, training, and interpersonal skills.  

Organizational & Project Skills 

• Strong organizational and time-management skills with the ability to manage multiple projects and deadlines. 

• Self-starter with a proactive mindset and a commitment to quality and continuous improvement.  

MINIMUM SKILLS REQUIREMENTS 

• Ability to interpret and clearly communicate complex analytical and scientific data. 

• Strong written communication and technical editing skills. 

• Familiarity with E&L regulatory frameworks and industry standards. 

• Effective collaboration skills with cross-functional scientific teams. 

• Strong organizational and time-management skills with the ability to manage multiple documents and deadlines. 

• Proficiency with standard documentation tools and document control practices. 

• A self-starter, motivated person who possesses excellent interpersonal skills capable of effectively interacting and communicating with all departments and client personnel.