Director, Medical 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 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 “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our 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 Director, Medical Writing to join our team. The Director, Medical Writing works to drive and shape the medical writing processes, strategies, and document generation and maintenance. The position will lead medical writing activities and manage a team. The Director will work flexibly across a number of preclinical and clinical stage projects, providing medical writing expertise and oversight, including data review. To be successful, the candidate will be a strong communicator, will be able to maintain excellent collaborative working relationships, and will have outstanding clinical writing skills.

This position reports to the Senior Director, Medical Writing and will be in 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. Relocation and immigration support will be provided, if required. This role is a hybrid position, requiring a minimum of 2 days per week in the office.
RESPONSIBILITIES:
• Provide strategy and support in the best practices of medical writing for the development organization.
• Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and act as the Medical Writing lead in IND/NDA submissions.
• Lead Medical Writing and cross-functional process improvement initiatives on document standards, template development, and document processes.
• Plans, writes, edits, and formats essential clinical development documents, including but not limited to: protocols, Investigator's Brochures, clinical study reports, narratives, IND and NDA modules, and briefing documents.
• Maintains timelines and workflow of writing assignments and ensures timely completion.
• Manages projects from start to completion, including the efficient review and finalization of documents produced.
• May act as the lead writer in a program; strategizes with cross functional team to prioritize documents and ensure timely completion.
• Represents Medical Writing on multiple project teams and serves as subject matter expert for clinical development documents.
• Works collaboratively within a team environment and interacts directly and independently with all relevant groups.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices. Interviews, mentors, and assists in the integration of medical writing staff as needed.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some international travel may be required.
• Other duties as assigned.
QUALIFICATIONS:
• Minimum undergraduate degree. 10+ years of relevant management & clinical writing experience or combination of degrees and experience.
• Recognized as a subject matter expert in a broad range of regulatory documentation.
• Strong l