Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of next-generation multifunctional biotherapeutics. 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
The Senior Medical Writer is responsible for developing high-quality regulatory documents that support global clinical development of Zymeworks’ investigational drug products as well as publications that support dissemination of scientific and clinical data to healthcare professionals. The Senior Medical Writer is also a key member of cross-functional clinical study teams.
This position will report to the Director of Medical Writing and will be based in our Seattle, WA or Vancouver, BC office.
• Leads development and authoring of program-level and study-specific regulatory documents, including protocols, protocol amendments, Investigator’s Brochures (IBs), clinical study reports (CSRs), 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.
• Provides strategic guidance on development of statistical outputs for regulatory documents and publications in collaboration with biometrics and other applicable functional areas.
• Critically analyzes and interprets clinical data to write IBs, CSRs, publications, and other documents as required.
• Interacts with document contributors, including medical experts, biostatistics, clinical operations, CMC, preclinical, toxicology, clinical pharmacology, and regulatory affairs to ensure appropriate collaboration and input into document development.
• Leads cross-functional team-level and management-level document reviews and comment adjudication meetings.
• Develops and manages document-specific timelines to ensure on-time deliverables that support corporate goals.
• Serves as the functional area representative on clinical study teams and advises teams on content and format requirements for documents.
• Participates in the development of medical writing departmental infrastructure, including standard operating procedures, work instructions/guidelines, templates, style and content guides, and document quality control to ensure consistent preparation of high-quality medical writing deliverables.
• Assists in the interviewing, mentoring, and integration of internal medical writing staff as needed.
• Maintains subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines.
Qualifications and Experience
• A minimum of 7 years of medical writing experience in the biopharmaceutical industry plus a university degree in a life-science-related discipline, health-related field, communications, or technical writing is required OR an advanced scientific degree (PhD, PharmD, or MS) plus 5 years of medical writing experience in the biopharmaceutical industry.
• Excellent writing skills coupled with ability to edit complex material to ensure accuracy, clarity, and effectiveness.
• Understanding of drug development process and the regulatory environment, including FDA/ICH guidelines preferred.
• Excellent attention to detail, multitasking, prioritization, and flexibility.
• Excellent communication skills with proven ability to interact in a team environment.
• Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information.
• Excellent organization skills and flexible attitude with respect to work assignments and new learning.
• Strong word processing and Microsoft Office Suite skills; advanced skills in Microsoft Word and proficiency in Excel and PowerPoint.
Why Work for Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.