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Senior Manager, Medical Writing


[ April 27, 2018 ]

We are seeking a Sr. Manager, Medical Writing to join our Clinical Development Team. This is a permanent full-time position, and the incumbent will be required to work 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. This position can be located in Vancouver, BC or Boston, MA.

RESPONSIBILITIES:

• Supervises and mentors Medical Writers and other Xenon personnel as appropriate
• Responsible for overall performance management of Medical Writers and ensuring adherence to GxP and SOPs
• Critically evaluates, analyzes and interprets the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Writes and edits 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, presentation materials, and publications to medical journals
• Maintains timelines and workflow of writing assignments and ensures timely completion
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with ICH templates and applicable style guides
• Works collaboratively within a team environment and interacts directly and independently with all relevant groups (internal and external) to coordinate all facets of writing projects, ensuring all assigned activities are managed appropriately
• Supervises and coordinates with external Medical Writers and service providers as needed
• Contributes substantially to, or manages, production of interpretive guides
• Takes ownership of a given assignment; proactively consults with other team members and department representatives for information or guidance as necessary
• Develops and updates relevant standard operating procedures as required

QUALIFICATIONS:

• At least 10 years of previous experience in the pharmaceutical/biopharmaceutical industry or at a clinical contract research organization (CRO), preferably in neurosciences
• At least 10 years of industry regulatory writing and clinical medical writing experience
• A Bachelor’s, Master’s or PhD in a scientific, medical or clinical discipline
• 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
• Comprehensive knowledge and understanding of ICH-GCP and US, Canadian and EU regulatory environments; previous experience with CTA and IND 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

To apply for this position, please e-mail your resume , cover letter and  a written sample of a clinical study report summary (redacted) or protocol summary (redacted) that you have written to careers@xenon-pharma.com and include “Medical Writing” in the subject line. All attachments must be saved as one file and be named: “Your Full Name – Medical Writing”. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.