Title: Sr. Specialist / Technical Writer
Client: Biotechnology company
Contract/Perm & duration: 12-month contract (possibility of extension/conversion)
Location: Toronto (remote, occasional onsite days if needed)
Pay Rate: $35-45/hr
Description of Position: Our cutting-edge biotechnology client is seeking a talented Sr. Specialist / Technical Writer to join the growing Manufacturing Science & Technology (MS&T;) group. The preferred location for the role is Toronto, Ontario to facilitate engagement with the broader Technical Operations organization. With the scope of leading technology transfers and broader technology implementation initiatives, the MS&T; team has a need for a dedicated role that interfaces with adjacent functions including Research, Non-clinical, Analytical Development, Manufacturing, Quality Control, and Quality Assurance. As a key contributor within the function, this role will drive revisions to internal procedures while developing templates that can be applied to a variety of source documents such as protocols and technical reports. In addition, this role will be trained in the Quality Management System to ensure appropriate reviews and assessments are documented for relevant Change Controls, Deviations, etc. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to contribute to innovate cellular therapies that have the potential to impact patients’ lives.
Responsibilities: Accountable for key internal procedures related to technology transfers and annual reports
Developing, revising, and implementing suitable templates for cross-functional use




Creating and revising standard operating procedures
Supporting the management and timely closure of quality events
Facilitating comment resolution and driving cross-functional discussions to ensure alignment, timely decision-making, and document progression
Taking charge of various technical documents including protocols and reports with appropriate support from technical experts
Proactively establishing standards and procedures for accurate and timely drafting of technical content
Driving preparation of Information Requests, Briefing Books, and other regulatory submissions with support from subject matter experts
Developing reporting tools in partnership with Quality Assurance and CMC Strategy
Minimum Requirements: MSc. degree in a Biological Science, such as Biochemistry, Immunology, Molecular Biology, or similar
5+ years of experience in technical writing with relevant certifications and affiliations
Experience working with Quality Management Systems
Knowledge of ICH guidelines and eCTD formatting
Expertise in technical writing as it pertains to regulatory submissions and scientific writing for publications
Strong English written and verbal communications skills
Ability to work in a fast-changing environment
Strong project management skills, with the ability to collaborate effectively with cross-functional teams and deliver high-quality documents on time
Collaborative team player with proactive approach to workContinuous improvement mindset, with the ability to identify and implement initiatives that increase efficiency and drive progress

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📌 Sr. Specialist / Technical Writer (Ontario)
🏢 Apex Systems
📍 Ontario