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.
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.
- 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 to support high quality deliverables.
- Leads cross-functional team-level and management-level document reviews and comment adjudication meetings.
- Develops and manages document-specific timelines to ensure that deliverables are completed on time and of high quality to 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.
Education 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.
Skills and Abilities:
- Excellent writing skills coupled with ability to organize and present complex material with accuracy, clarity, and effectiveness.
- Understanding of drug development process and the regulatory environment, including FDA/ICH guidelines.
- Critical thinking, excellent attention to detail, and high quality standard.
- Multitasking, prioritization, and flexibility
- Excellent communication skills with proven ability to interact in a team environment and share expertise.
- Comfortable in a fast-paced 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.
- An equivalent combination of education and experience may be considered.
- Embody and champion Zymeworks’ values: Innovate. Act with Integrity. Collaborate. Care.
- Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.
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.