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Medical Writer

Company: Burning Rock Dx
Location: Irvine
Posted on: November 22, 2021

Job Description:

Job Title: Medical Writer Reports to: Project Manager, FDA Regulatory Affairs CDxClassification: Full-time Position Summary: The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, design control, quality management, FDA regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following: --- Prepares, edits, and finalizes FDA PMA study protocols, design control, quality management, regulatory documents, clinical publications--- Participates in scientific communication planning, including development of strategic medical communication plans --- Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents --- Works closely with the study team to ensure that results and messages in FDA IVD documents accurately reflect the data in TFLs and other information sources. --- Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes --- Collaborates with lab scientists, biostatisticians, BD team interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents --- Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed--- Works closely with Project Manager, FDA Regulatory Affairs CDx and the study team to reach consensus on timelines for deliverables--- Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance--- Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations--- Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables--- Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system--- Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the experience, knowledge, skill, and/or ability required. --- At minimum Bachelor degree or equivalent in medical-related field or life science. --- Bachelor's degree +1 years relevant medical writing experience, especially writing in one or more of the oncology clinical testing areas (prior FDA IVD experience is a BIG PLUS).--- An understanding of the genetic testing process --- Broad experience managing the medical writing responsibilities associated with multiple studies at various stages --- Experience in interacting with cross functional study team members

Keywords: Burning Rock Dx, Irvine , Medical Writer, Advertising , Irvine, California

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