Job Description

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.

Company 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.

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 can be based in our offices in Vancouver BC or Remote (CA).

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such. To be considered fully vaccinated, all 3 doses are required.

Key Responsibilities

• Supports medical writing deliverables, including populating content, updating content, generating redline versions or rendition to pdf format, to ensure the delivery of high quality clinical regulatory documents on time and in adherence to established processes and regulatory guidance.
• Manages or supports document review process, including identification of document reviewers and approvers, circulation to internal and external authors and tracking of responses using multiple review platforms.
• Supports the development of publications, including manuscripts, abstracts, posters, and slide presentations in collaboration with internal clinical study teams and external researchers.
• Manages templates and style guide; and assist internal team with usage and compliance.
• Manages reference citation/bibliography software (e.g., Endnotes), and prepares reference citations and bibliography as needed.
• Manages compilation of CSR appendices, including tracking of deliverables and ensuring appropriateness and high quality of appendices in collaboration with stakeholders to facilitate CSR publishing.
• Assists and manages the updates of clinical trials disclosure
• Conducts data checking, editorial and formatting review of medical writing deliverables to ensure accuracy, consistency and high quality.
• Serves as the functional area representative on clinical study teams and project teams as needed, works collaboratively with colleagues across functions to achieve results.
• 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.
• Actively works to foster an environment of effective and collaborative working relationships amongst employees, management, and external partners.

Qualifications and Education

• BSc (or diploma) or related experience in the pharmaceutical industry with focused experience in document process.

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.
• Flexible attitude with respect to work assignments and new learning
• Pharmaceutical research and development experience beyond medical writing is a plus.
• Experience using a variety of references management systems (e.g., Endnote).
• High standard for quality, excellent attention to detail and a methodical, diligent approach to proofreading, ensuring consistency in style and format.
• Proficient In document management systems and publication software and process.
• Experience In working on clinical submission documents (e.g., clinical study reports, protocols, Investigator's brochures) and assembly of electronic submissions in compliance with technical editorial and format requirements
• Understanding the use of templates and style guide.
• Experience and skill in document layout and formatting.
• Understanding of FDA and ICH regulations and guidelines.
• Strong word processing and Microsoft Office Suite skills; advanced skills in Microsoft Word and proficiency in Excel and PowerPoint, and Adobe Acrobat.

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.