Principal Medical Writer

Clinical Development United States


Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.

About the Position

Zymeworks is seeking a highly motivated professional who is looking to grow their career with our company.

This position will report to the Senior Director, Medical Writing and will be based in Vancouver, BC or Seattle, WA. 

Key Responsibilities

  • Leads development and authoring of program-level and study-specific regulatory documents, including protocols, protocol amendments, Investigator’s Brochures, clinical study reports, sample informed consent forms, briefing documents, and other documents needed to support regulatory interactions and filings.
  • Leads development and authoring of publications, including manuscripts for peer-reviewed journals, and abstracts, oral presentations, and posters presentations for medical/scientific congresses and medical society meetings in collaboration with internal clinical study teams and external researchers and/or scientists.
  • Conducts peer-review of medical writing deliverables to ensure consistency, accuracy and clarity of all documents.
  • Collaborates with Biometrics and other functional areas to provide strategic guidance in developing statistical outputs required for a variety of clinical regulatory documents and publications.
  • Collaborate with Biometrics In the development of case report forms and participate In the review of statistical analysis plans and data outputs.
  • Serves as the functional area representative on clinical study teams and advises teams on content and format requirements for documents.
  • Adheres to established regulatory standards including, but not limited to, ICH and FDA guidelines, company standard operating procedures (SOPs), work practices and approved templates.
  • Assists in the development of SOPs and work practices.
  • Develops departmental infrastructure, process documents, templates, and trackers in collaboration with other functional areas.
  • Ensures regular and proactive communication among department staff. Monitors, tracks and reports program status to key stakeholders including senior management.
  • Actively works to foster an environment of effective and collaborative working relationships amongst employees, management and external partners.

 Qualifications and Education

  • MS/MA or higher advanced degree with a minimum of 8 years’ related experience or an equivalent combination of education and experience.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
  • Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
  • Demonstrated high level of integrity and ethics.
  • Solid understanding of scientific methods, science and medical terminology in the area of oncology. Knowledge in the fields of autoimmune diseases and neurology, an asset.
  • Previous experience preparing submissions for oncology drugs using antibodies and antibody drug conjugates.
  • Pharmaceutical research and development experience beyond medical writing.
  • Experience performing literature searches and preparing grant applications, abstracts, manuscripts, annual reports and press releases.
  • Technical expertise in nonclinical and clinical oncology studies.
  • Exceptional oral and written communications skills and the ability to organize and present complex material clearly, concisely and effectively.
  • Extensive knowledge of English grammar.
  • High standard for quality, excellent attention to detail and a methodical, diligent approach to proofreading, ensuring consistency in style, grammar and punctuation.
  • Experience and skill in document layout and formatting.
  • Solid understanding of FDA and ICH regulations and guidelines.
  • Proficiency with MS Office, Visio and Adobe Acrobat.
  • Ability to travel, as required (up to 20%).

Why work for us?

Innovation. Act with Integrity. Collaboration. Care

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

 

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.

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