Technical Writer, Analytical Development

**About Apotex Inc.**

**Job Summary**:
Primarily responsible for creating and revising all analytical test methods (chemical and physical) and specifications generated in Analytical R&D as per current Apotex format and posting the methods on Apoweb. Responsible for the completion of R&D Change Control Requests (CCRs) in Trackwise for method creation to transfer of methods to the commercial site. Responsible for support and completion of R&D CCRs in Trackwise for generation and update of specifications. Also responsible for creating, updating and maintanance of Apotex technical report templates.

**Responsibilities**:

- Requests product codes for new projects from Consultant, Financial data Processes (for SAP product codes) or from Supervisor, NPL-Master Prod&Pkg Docs (for product acronyms) and assigns new method numbers for Analytical R&D and ARPL, as applicable, using Excel database.
- Creates and revises analytical test methods generated in Analytical R&D using current method templates, for example: chromatographic methods, physico-chemical test methods, dissolution test methods.
- Assists PD-SD chemists, Chemistry & Compendia associates, and ARD scientific leaders with CCR creation and reviews all associated documents prior to management approval.
- Initiates and supports change controls as relevant to R&D specifications.
- Liaises with Analytical R&D, Commercial labs, QC Documentation group, RA and R&D QA for CCR’s signatures and impact analysis.
- Checks the method files into Content Server and creates workflow in Workflow Manager.
- Posts all analytical methods on Apoweb (Analytical Test methods site), maintains the site archive, and adds all new product/excipient names to the Apoweb.
- Creates and maintains Excel database of R&D analytical methods and the method change histories.
- Communicates the status of analytical method and R&D specifications change control to relevant parties in a timely manner.
- Works with ARD Scientific Leaders and supervisors to ensure test method templates are current.
- Creates, updates and maintains ARD technical report templates (including those for global regulatory submissions).
- Consults ARD staff on technical features of MS Word.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Education
- Recognized post secondary education in Chemistry or related field
- Knowledge, Skills and Abilities
- 5+ years experience in Technical Writing, preferably in the pharmaceutical industry.
- Knowledge of basic principles of major analytical techniques and associated scientific calculations.
- Advanced knowledge and proficiency in Microsoft Word, Excel and PowerPoint.
- Excellent typing and proofreading skills.
- Excellent communication skills, verbal and written.
- Advanced organizational skills and attention to details.
- Working knowledge of SAP is an asset.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.