Sr. Specialist / Technical Writer

Apex Systems; Toronto; Hybrid; CAD 48,000 - 62,000; Full time

Job summary

Apex Systems is seeking a Sr. Specialist / Technical Writer for a biotechnology client in Toronto on a 12-month contract with potential extension.

The role leads technology transfers and the drafting of protocols and technical reports, interfacing with Research, QA, Manufacturing, and Compliance. Ideal candidates have an MSc in Biological Sciences, 5+ years of regulatory writing experience, and strong English communication and cross-functional collaboration skills.

Qualifications

• MSc degree in Biological Sciences or related field.
• 5+ years of technical writing experience with regulatory submissions.
• Experience with Quality Management Systems and ICH guidelines.
• Excellent command of English written and spoken.
• Strong project management and cross-functional collaboration.

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 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

Skills

Strong English communication

Project management

Cross-functional collaboration

Attention to detail

Education

Master of Science in Biological Sciences

Job description

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 innovative 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