Senior Medical Writer

Boston, MA, USA Req #203
Friday, March 8, 2024
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 Senior Medical Writer to join our team. The Senior Medical Writer works flexibly across a number of preclinical and clinical stage projects, providing medical writing expertise, including data review activities. The role is hands on, requires frequent collaboration and excellent working relationships with various internal groups.

This position reports to the Senior Director, Medical Writing.

RESPONSIBILITIES:
  • Plans, writes, edits, and formats clinical development documents, including but not limited to protocols, Investigator's Brochures, study reports, informed consent forms, layperson summaries, and briefing documents.
  • Maintains timelines and workflow of writing assignments and ensures timely completion.
  • Ensures documents are well-organized, accurate, consistent, and in compliance with applicable company SOPs and other guidance documents and regulations.
  • Understands clinical research statistical methods and is adept at integrating and summarizing data from various sources in a clear and concise manner.
  • Ensures consistency across documents, to include standard program lexicon and writing standards.
  • Works with quality control and quality assurance editors during audit of clinical documents to ensure timely response to findings.
  • 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. Leads round table discussions effectively and efficiently. Facilitates resolution of comments.
  • International travel may be required.
  • Act in accordance with SOPs and Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
  • Other duties as assigned.
QUALIFICATIONS:
  • A bachelor’s, master’s, or PhD in a scientific, medical, or clinical discipline.
  • A minimum of 4 years of industry regulatory writing experience.
  • A thorough understanding of scientific methodology, clinical data, 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.).
  • Excellent oral and written communication skills; proficient in written and spoken English.
  • 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.
  • General knowledge and understanding of ICH-GCP and US, Canadian, and EU regulatory environments; previous experience with IND and NDA submissions preferred.
  • Excellent interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.
  • Job level is commensurate with experience.

The base salary range for this role is $107,600 to $136,100 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.