Technical Writer / Qc Specialist

A Maryland-based preclinical contract research organization (CRO), providing services in the fields of drug, vaccine, and medical device development and testing. Services offered range from early product discovery through GLP-compliant studies for regulatory submissions. The company offers integrated preclinical drug development services including cellular and animal disease model design and development, non-GLP and GLP efficacy, toxicity, biodistribution, and product release studies in a broad range of animal species.

Job Summary: We are seeking a detail-oriented and experienced Technical Writer/QC Specialist. The successful candidate will be responsible for producing clear and accurate documentation, ensuring quality control of scientific reports, and supporting regulatory compliance efforts. This role requires a strong background in scientific writing, attention to detail, and an understanding of preclinical research processes.
Responsibilities:
Responsibilities include but are not limited to:
Technical Writing
Prepare and review scientific documents, including study protocols, reports, and standard operating procedures (SOPs).
Ensure clarity, accuracy, and compliance with regulatory and industry standards.
Collaborate with scientists, researchers, and other stakeholders to gather information and develop comprehensive documents.
Quality Control
Conduct thorough reviews of scientific documents to ensure accuracy, consistency, and adherence to established guidelines.
Verify data and cross-check information for completeness and correctness.
Identify and rectify errors or inconsistencies in documentation.
Regulatory Compliance
Ensure all documentation meets regulatory requirements and guidelines.
Assist in the preparation of regulatory submissions and audit responses.
Stay updated on regulatory changes and industry best practices to ensure compliance.
Collaboration and Communication
Work closely with cross-functional teams, including research scientists, project managers, and regulatory affairs specialists.
Provide clear and concise feedback to authors and contributors to improve document quality.
Assist in training staff on documentation standards and best practices.
Qualifications Bachelor's degree in life sciences, biotechnology, pharmacology, or a related field
Minimum of 2 years of experience in technical writing and quality control within the biopharmaceutical or preclinical research industry.
Strong understanding of preclinical research processes and regulatory requirements.
Excellent written and verbal communication skills.