Principal Clinical Medical Writer

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 BioMarin
• Other tasks as assigned.

Experience

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, and integrated results reporting.

Management Experience: 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.

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).

Regulatory: Ability to plan and manage development of standalone regulatory documents (eg, protocols, investigator brochures, clinical study reports, IND annual reports) in context of regulatory requirements and guidances, development program plans, and organizational business needs. Prior familiarity with standard eCTD IND/NDA work, including Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format, Integrated Summary of Safety (ISS), and Integrated Summary of Efficacy (ISE). Support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US and EMEA submissions and to provide recommendations for changes in documentation in response to new or modified regulations and guidances.

Project Management: Ability to plan, resource, and assign multiple simultaneous document development projects (standalone and complex dossiers) with shifting priorities. Ability to keep CMW line management apprised of program document status, to anticipate potential issues within a program, and to raise those issues to CMW line management with proposed mitigations/solutions. Ability to support staff in renegotiating timelines during development as necessary.

Program Management: Capable of managing and maintaining multiple timelines governing multiple projects within a program. Capable of performing resource assessments (short- and long-term) based on projected project needs within a program. Capable of anticipating potential issues within a program and raising those issues to CMW line management with proposed mitigations/solutions.

Communication: Capable of well organized, concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.

Education

Masters (MS) or higher degree preferred; scientific focus desirable. 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.