Medical Writer II

Clinical Development Seattle, Washington


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. 

The Medical Writer II is responsible for researching, creating, editing and coordinating the production of clinical documents. This individual works in collaboration with several internal departments including Clinical Development, Clinical Operations, Drug Safety and Risk Management, Regulatory, Clinical Data Management, and Biostatistics. 

The Medical Writer II reports to the Senior Director, Medical Writing and will be based in Seattle, WA or Vancouver, BC.

 Key Responsibilities

  • 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.
  • Supports or leads the clinical trials disclosure process and preparation of publications (e.g., conference presentations and manuscripts) including liaising with cross-functional stakeholders to ensure high quality, accurate and timely deliverables that meet industry and regulatory guidelines and standards.
  • Ensures document content and style adhere to regulatory guidelines and complies with company SOPs and style guides.
  • Develops and manages document-specific timelines to ensure that deliverables are completed on time and of high quality to support corporate goals.
  • Communicates document development progress to project teams and management, and proactively raises issues to management and project teams.
  • Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed.
  • Serves as functional area representative on clinical study teams and advises teams on content and format requirements for documents.
  • Peer-reviews of documents generated by other medical writers.
  • Participates In departmental and Interdepartmental process Improvement as needed.
  • Keeps abreast of industry updates and professional development through workshops and conferences and be able to share the knowledge with other members in the department.
  • Integrates various sources of information into a uniform style and language for regulatory compliance.
  • Other duties as needed. 

Education and Experience: 

  • A minimum of 2 years of medical writing experience in the biopharmaceutical industry plus bachelor's degree in a life-science-related discipline, health-related field, communications, or technical writing is required OR an in the biopharmaceutical industry.

Skills and Abilities:

  • Prior medical technical writing experience within the biotech/pharmaceutical/CRO realm.
  • Experience and participation in preparation of clinical documents for regulatory submissions (e.g. clinical protocols, INDs, NDAs, BLAs).
  • Understanding of drug development process and the regulatory environment, including FDA/ICH guidelines and principles of GXP/ICH/CTD standards.
  • Familiarity with therapeutic area of Oncology preferred.
  • Excellent writing skills coupled with ability to organize and present complex material with accuracy, clarity, and effectiveness.
  • Exceptional attention to detail critical thinking and high-quality standard.
  • Outstanding communication with the ability to interact with cross-functional team members and incorporate diverse feedback into high-quality documents.
  • Demonstrated experience working in a fast-paced environment with an ability to manage a variety of projects simultaneously.
  • Strong organization skills and flexible attitude with respect to work assignments and new learning.
  • Fluency in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
  • Advanced knowledge of MS Word and proficiency with Microsoft Office Suite.
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.
  • Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care.
  • An equivalent combination of education and experience may be considered. 

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://zymeworks.bamboohr.com/jobs/.

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

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