Principal Clinical Medical Writer at BioSpace San Rafael, CA

Responsibilities

• Oversight responsibilities for Medical Writing staff
• Works with the Head of Medical Writing to establish and maintain timelines for program planning.
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (e.g. PBRERs, DSURs)
• Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/Module 5 clinical or integrated summaries).
• Manages study team participation in the preparation of such documents, including scheduling and chairing meetings, developing and managing timelines, and managing the document review and comment adjudication processes
• Represents CMW at cross-functional team meetings (e.g. study team, development team, other sub-teams).
• Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
• Works effectively with cross-functional groups within Bio Marin
• Other tasks as assigned.

This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable Bio Marin to reduce writing-related CRO and contractor costs, increase Clinical Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.

Note: Masters (MS) or higher degree preferred; scientific focus desirable. Minimum requirement:
Regulatory

• Standalone regulatory documents (e.g., protocols, investigator brochures, clinical study reports, IND annual reports)
• Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format
• Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)

• At least 8 years of experience as a medical writer in the pharmaceutical industry. Evidence of medical writing career development desirable, e.g., European/American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
• Management:
  Prior administrative and/or functional management experience as a manager of a medical writer team or department in a clinical development setting preferred but not required. Demonstrated leadership abilities.
• Demonstrated ability to plan timelines and resources for multiple documentation projects with shifting priorities.
• Experience with delegating and overseeing projects and tasks.
• Clinical Studies:
  Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets.
• Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.
• Advanced applied knowledge of: documentation required for the conduct of clinical studies; protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs); study results reporting; integrated results reporting.
• Direct experience with documentation in all phases of drug development. Medical Writing:
  Writing high-quality documents that support corporate goals and objectives.
• Experience writing, reviewing, or editing protocols, clinical study reports, INDs, BLA/NDAs, periodic safety documents, and regulatory briefing books required.
• Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.
• Ability to interpret and create complex tabular and graphical clinical data presentations.
• Ability to interpret basic clinical laboratory tests.
• Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
• Computer/office equipment Skills:
  Proficient in Microsoft Word (including the use of templates), Microsoft Copilot, Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
• Experience using document management software (e.g., SharePoint, Veeva)
• Experience with scanners, printers, and copiers.
• Ability to plan and manage development of the following documents in context of regulatory…