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.
This position reports to a Senior Director, Medical Writing and will be based in Seattle, WA.
- 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.
Education and Experience:
MS/MA or higher advanced degree with a minimum of 8 years’ related experience or an equivalent combination of education and experience.
Skills and Abilities:
- 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?
At Zymeworks, we stand for innovation, integrity, collaboration and care.
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 https://jobs.jobvite.com/zymeworkscareers.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging opportunity, please apply online https://jobs.jobvite.com/zymeworkscareers/job/oR3YdfwP. Due to the high volume of applicants, only those selected for interviews will be contacted.
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.Apply Now