Manager, Technical Writing, Cmc
5 months ago
**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.
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