Technical and Scientific Writer

The Centre for Probe Development and Commercialization **(CPDC) **is a global leader of next-generation radiopharmaceuticals. At CPDC we are working with our partners to discover, develop and distribute the next generation of imaging agents and targeted radiotherapeutics for the detection and treatment of human diseases such as cancer. Our Centre has the full range of scientific, technical, regulatory and business expertise combined with specialized infrastructure required to translate radiopharmaceuticals from clinics to the commercial marketplace. Radiopharmaceuticals are perishable products that require just-in-time manufacturing. CPDC's success in the radiopharmaceutical industry results in the ability of our talented staff to develop reproducible processes that yield high quality products while adhering to international regulations governing nuclear safety, transportation of goods, and pharmaceutical manufacturing. Our staff takes pride in the impact we make every day in the lives of patients across the globe.
**About the Role**:
The **Technical and Scientific Writer** is a strong writer with excellent verbal and written English. They support the quality control and analytical development team through preparation of professionally written documents used in all aspects of laboratory compliance, product testing, and batch release.

**Responsibilities**:

- Plan, implement and successfully complete assigned documentation for Analytical Development and Quality Control projects and tasks in a timely fashion while ensuring consistent high quality and compliance with Good Manufacturing Practices (cGMP). Ensure that daily work activities are aligned with a client-driven production and stability plan/calendar, and work with management to accommodate last minute changes.
- Initiate change controls to implement/revise/improve programs and methods and monitor completion of all work in a timely fashion. Follow up to close change controls on time.
- Conduct research and collect all necessary information to support documents being generated.
- Write (author), revise, review, and approve technical documents, validation documents (protocols, reports), guidelines, policies, standard test methods (STMs), standard operating procedures (SOPs), specifications, forms, master batch records, etc. according to regulatory guidelines (ICH, USP, etc.) for review by management, QA and/or customers. Provide peer review and provide input for co-workers. Assist in improving or creating templates as needed.
- Write (author), revise, and review quality systems documents including investigation reports, non-conformance reports, corrective and preventive action reports, root cause analysis, audit reports, gap analyses, and risk assessments.
- Support, as needed, the documentation of items required for new equipment purchases and installation (quotes, URS, change control, SOPS, STMs, forms, IQ/OQ/PQ, etc.)
- Assist QA on vendor qualification tasks.
- Provide back-up support for technical review of laboratory records and notebook; create the material or batch release certificate of analysis, as needed.
- Coordinate and monitor completion of documents with coworkers within the quality team (quality assurance, quality control, analytical development). Act as point of contact for other departments and team members for matters related to documentation.
- Provide training in technical writing and data presentation skills for team members.
- Prepare presentations for internal and external (client) review to summarize documentation status and participate in client meetings if required.
- Participate in departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed by the QC/AD team.
- Conduct all work in accordance with company Standard Operating Procedures (SOPs) and raise any deviations immediately to the attention of Lab Management and Quality Assurance.
- Maintain a working understanding of and ensure timely review of updates for the following:

- Health Canada and FDA GMP requirements for sterile pharmaceuticals
- International compendia such as USP, EP, JP, etc.
- ICH and EANM Guidelines
- Established business processes, protocols and work orders.
- Document and communicate the compendia changes to the team.
- Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.
- Understand and work under the Canadian Nuclear Safety Commission regulations.
- Conduct self and all activities with the highest level of competency and reliability, follows company policies and procedures and shows support for the organization’s goals and values.
- Show understanding for unique challenges of radiopharmaceutical industry with respect to shifts, hours, and overtime.
- Complete all other assigned duties, as requested.

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Required Education/Experience: *
- B.Sc. in Chemistry, Biochemistry, Biotechnology, or a related discipline.
- M.Sc. is preferred.
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