Xenon Pharmaceuticals Inc

In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.. The Manager, Technical Writing, CMC, will author and manage the review and approval of CMC regulatory documents, including Module 2 and Module 3 CMC regulatory submissions, technical reports, and SOPs in close collaboration with critical functions within the CMC function.. Plan, manage and execute the authoring and review of CMC regulatory documents and deliver on timelines for submissions.. 5+ years working in the pharmaceutical industry, with an emphasis on authoring CMC regulatory content.. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

technical writing

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:
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures. In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
About the Role: We are seeking a Manager, Technical Writing, CMC to join our growing team. The ideal candidate should be an independent and self-directed contributor who will be responsible for converting scientific data into clear, scientifically sound, well-structured scientific, technical, and regulatory documents intended for global health authorities and internal and external stakeholders. The Manager, Technical Writing, CMC, will author and manage the review and approval of CMC regulatory documents, including Module 2 and Module 3 CMC regulatory submissions, technical reports, and SOPs in close collaboration with critical functions within the CMC function.
This position reports to the Senior Director, Regulatory Affairs, CMC and will be in Vancouver, BC, Canada or Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience.
RESPONSIBILITIES:
Author and edit the CMC sections of regulatory filings across all assets and clinical and commercial phases, including Module 2 & 3 submissions, IND/IMPDs, marketing applications, supplements, amendments, and annual reports, as needed.
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.
Develop processes and best practices to facilitate organization of information in preparation for clinical and marketing applications for Xenon products.
Collaborate with technical subject matter experts (analytical, drug substance and drug product development) to review and interpret data and author technical development reports.
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.
Demonstrated, hands-on experience, managing and preparing regulatory submissions including INDs/CTAs and/or marketing applications, supplements and variations.
Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs.
The base salary range for this role is $101,900 to $123,400 USD ; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
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. US positions only:Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here .
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted. #J-18808-Ljbffr

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