Manager/Senior Manager, Medical Writing

Location
Boston, MA
Posted
Nov 26, 2021
Ref
Req #39
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders. 

At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.

Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us.  We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon.

We are seeking a Manager or Senior Manager, Medical Writing to join our team. 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.

This position reports to the Vice President, Clinical Operations and will be located in the Boston, MA, USA location. 
 

RESPONSIBILITIES:

  • 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.


QUALIFICATIONS:

  • 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.