Manager, Technical Writing, Cmc

6 months ago


Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

**Who We Are**:
**Xenon Pharmaceuticals (NASDAQ**: XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

**What We Do**:
**About the Role**:
**RESPONSIBILITIES**:

- Plan, manage and execute the authoring and review of CMC regulatory documents and deliver on timelines for submissions.
- Manage and contribute strategy to responses to CMC queries and Requests for Information received from global health authorities.
- Summarize scientific information from development reports and identify details relevant to regulatory clinical and commercial phase submissions supporting regulatory strategy.
- Review documents for consistency and quality.
- Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed.
- Other duties as assigned.

**QUALIFICATIONS**:

- A Bachelor’s or Master’s degree in pharmaceutical/life sciences, technical or medical writing, or a related field is strongly preferred.
- 5+ years working in the pharmaceutical industry, with an emphasis on authoring CMC regulatory content.
- Proficiency in evaluating data, summarizing reports, authoring, and reviewing documents, and communicating results to internal and external stakeholders.
- Extensive knowledge of eCTD structure and subsections.
- Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.



  • Vancouver, Canada AbCellera Full time

    AbCellera is breaking the barriers of conventional antibody discovery to bring better medicines to patients, sooner. Our engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic with precision and speed. We are seeking a Head of CMC Portfolio Management to...


  • Vancouver, Canada AbCellera Biologics Full time

    AbCellera is breaking the barriers of conventional antibody discovery to bring better medicines to patients, sooner. Our engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic with precision and speed. We are seeking a Head of CMC Portfolio Management to...


  • Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

    Who We Are:Xenon Pharmaceuticals ( NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...


  • Vancouver, Canada Workday Full time

    Your work days are brighter here. At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market. And when we began to rise, one thing that really set us apart was our culture. A culture which was driven by our value of putting our...


  • Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

    **Who We Are**: **Xenon Pharmaceuticals (NASDAQ**: XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive,...


  • Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

    **Who We Are**: **At Xenon Pharmaceuticals (NASDAQ**: XENE), we are committed to providing a brighter future for patients suffering from neurological disorders. Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver innovative medicines for patients in need. We are looking for great...


  • Vancouver, Canada Abdera Therapeutics Full time

    **Who we are** Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies - one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while...


  • Vancouver, Canada Abdera Therapeutics Inc. Full time

    p>Who we areAbdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies - one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while...


  • Vancouver, British Columbia, Canada Abdera Therapeutics Inc. Full time

    Abdera Therapeutics Inc. is a cutting-edge precision oncology company that specializes in developing targeted radiation therapies for cancer patients with limited treatment options.Our company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells.We are...

  • Technical Editor

    6 months ago


    Vancouver, Canada Two Worlds Consulting Full time

    **Who is Two Worlds Consulting?** Two Worlds Consulting (TWC) is a Canada-wide social and environmental consultancy. We work with Indigenous Nations, the private sector, and government to support rigorous process, informed decision-making, and shared prosperity. Our commitment to people—and to more than one perspective—is clear in everything we...


  • Vancouver, British Columbia, Canada KNG Technical Inc. Full time

    KNG Technical Inc. is seeking a highly skilled and experienced Senior Technical Support Specialist to join our team in Vancouver, BC.About the Role:This is a full-time position that requires travel up to 40% of the time, including overnight stays. The ideal candidate will possess excellent analytical, problem-solving, and communication skills, with a strong...


  • Vancouver, British Columbia, Canada KNG Technical Inc. Full time

    We are seeking a highly skilled Senior Technical Service Specialist to join our team at KNG Technical Inc.As a Senior Technical Service Specialist, you will be responsible for delivering exceptional customer service by performing on-site installations, diagnostics, troubleshooting, and repairs of complex instruments and systems.ResponsibilitiesYou will...

  • Technical Writer

    7 months ago


    Vancouver, Canada SAP Full time

    We help the world run better Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly...

  • Technical Writer

    6 months ago


    Vancouver, Canada LTIMindtree Full time

    **About LTIMindtree** LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies - . As a digital transformation partner to more than 750 clients, LTIMindtree brings extensive domain and...


  • Vancouver, Canada A&K Robotics Full time

    Technical Project Manager **About us** A&K Robotics is a leader in self-driving technology. We develop autonomous vehicles that are changing how we move around our world. Our main product is an autonomous electric mobility pod designed to empower people to get around with more freedom and independence, starting in airports. We are working with the world’s...


  • Vancouver, Canada A&K Robotics Full time

    Technical Project Manager **About us** A&K Robotics is a leader in self-driving technology. We develop autonomous vehicles that are changing how we move around our world. Our main product is an autonomous electric mobility pod designed to empower people to get around with more freedom and independence, starting in airports. We are working with the world’s...

  • Technical Writer

    6 months ago


    Vancouver, Canada InfoObjects Full time

    Technical Writer Location: Hybrid (3 Days onsite)at British Columbia V6B 1M8 Canada Duration: +6 months JD: **About the Role** - Works closely with editorial, development, customer support, product management, and services to develop high-quality technical content. - Drafts, maintains, and edits content for release notes and release publications. -...


  • Vancouver, British Columbia, Canada KNG Technical Inc. Full time

    At KNG Technical Inc., we are seeking a highly skilled and motivated Technical Service Specialist to join our team in Aesthetic Field Service Engineer role.About the RoleThis is an exciting opportunity for a detail-oriented professional with excellent communication skills to provide exceptional customer service, technical support, and training to our...

  • Compensation Director

    1 month ago


    Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

    p>What We Do:We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b...


  • Vancouver, Canada AbCellera Full time

    AbCellera is a young, energetic, and rapidly growing biotech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. We are seeking a highly motivated Associate Scientist to join Analytical Development within the Process Analytics team...