Manager/Senior Manager, Medical Writing
Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is advancing an exciting pipeline of therapies for neurological disorders, with a particular focus on innovative treatments for epilepsy. Xenon has a number of promising therapeutics in clinical development, valuable collaborations with pharmaceutical partners, and innovative early-stage research underway and also has a strong balance sheet to support its continued growth in 2021 and beyond.
We are a collaborative, ambitious, and driven team with a common mission to improve the lives of patients with neurological disorders. Creating a healthy and productive work environment is a priority, and we understand the importance of investing in our employees’ growth and development. We support charities and volunteerism, knowing that when our people contribute to their local communities, they are gaining new experiences and becoming even better leaders. Xenon’s employees are smart, passionate, and driven by their incredibly important work to discover, develop and deliver new medicines for patients in need. We are looking for talented and determined individuals who thrive in a fast-paced and dynamic work environment to join our team during this transformative time for the company.
We are seeking a Manager or Senior Manager, Medical Writing to join our team. Reporting to the Associate Director, Medical Writing, the Manager/Senior Manager, Medical Writing works flexibly across a number of preclinical and clinical stage projects, providing medical writing expertise, including data review and analysis activities. The role is hands on, requires frequent collaboration and excellent working relationships with various internal groups.
- Plans, writes, edits, and formats essential clinical development documents, including but not limited to: clinical protocols, Investigator's Brochures, clinical study reports, informed consent forms, integrated safety and efficacy summaries, and briefing documents.
- Maintains timelines and workflow of writing assignments and ensures timely completion.
- Manages efficient review and finalization of documents produced internally and/or externally contractors and vendors.
- 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.
- Develops and updates relevant standard operating procedures as required.
- Acts 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.
- A Bachelor’s, Master’s, or PhD in a scientific, medical, or clinical discipline.
- 5-10 years of previous experience in the pharmaceutical/biopharmaceutical industry or at a clinical contract research organization (CRO), preferably in neurosciences.
- 5-10 years of industry regulatory writing and clinical medical writing experience.
- A thorough understanding of all phases of the drug development process and the interdependencies between Clinical Development and other functional areas (e.g., CMC, Nonclinical/Toxicology, Regulatory Affairs, etc.).
- Extensive experience in regulatory submissions presented to Health Authorities (e.g., clinical protocols, Investigator’s Brochures, clinical study reports).
- Strong understanding of clinical data and exceptional writing skills.
- Proven organizational skills and the ability to work across a variety of teams and manage multiple competing priorities.
- Expert in Microsoft Word, Excel, PowerPoint, and related word processing and electronic publishing tools.
- Experience with EndNote and StartingPoint templates desired.
- Comprehensive knowledge and understanding of ICH-GCP and US, Canadian, and EU regulatory environments; previous experience with CTA, IND, and NDA submissions preferred.
- Excellent oral and written communication skills.
- Good interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.
- Ability to travel on occasion.