Technical Writer

QSE7, a Pennsylvania-based consulting company, is seeking to hire several high-aptitude individuals to help us provide technical writing services to our Life Sciences customers. Our customers are large pharmaceutical, consumer healthcare and medical device companies. They are generally located in the Philadelphia and North New Jersey areas, and our services are performed primarily from our home offices and occasionally at client locations.

Job Responsibilities:

As a QSE7 technical writer, you will be expected to perform the following services for our clients:

• Leads complex documentation efforts across multiple products or domains, ensuring high-quality deliverables.
• Produces, reviews, and maintains documentation, ensuring accuracy, clarity, and consistency.
• Translates complex technical and process information into clear, user-friendly content.
• Collaborates with cross-functional teams and subject matter experts to gather requirements and develop comprehensive documentation.
• Develops and improves templates, SOPs, and publishing workflows to drive consistency and efficiency.
• Proactively identifies, escalates, and manages project risks with effective mitigation strategies.
• Independently researches unfamiliar topics and applies appropriate tools, standards, and methodologies.
• Applies industry standards and regulatory requirements (e.g., FDA, CE Marking, ISO) in documentation practices.
• Creates and maintains technical materials including SOPs, process documentation, procedure manuals, and specifications.
• Builds and manages repositories of reference materials and documentation assets.
• Influences stakeholders and leads communication across all levels to support informed decision-making.

Required Experience/Qualifications:

• Experience authoring and managing documents within Veeva QMS or similar electronic quality management systems (eQMS).
• B.A. or B.S. degree
• A minimum of five (5) years of technical writing experience
• Excellent oral, written, presentation and communication skills
• Leading/motivating cross-functional subject matter experts and project stakeholders
• Strong business and financial acumen
• Experience working in FDA regulated environments
• Proficiency in Microsoft Office suite of applications
• Demonstrated leadership & influencing skills across organizational levels is preferred

About QSE7:

Founded in 2016, QSE7 offers innovative and specialized consulting services to FDA-regulated Life Sciences companies. Our areas of focus include program/project management, process analysis, automated business process improvements, data analytics, technical writing and reporting. We strive to bring automation and efficiency to our clients’ processes by providing high-quality and intuitive solutions in an efficient, comprehensive manner.