Senior Medical Writer

About the role

The Senior Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

Responsibilities

• 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 (PBRERs, DSURs, etc.)
• Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries).
• Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
• Represents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams).
• Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met.
• Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
• Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Works effectively with cross-functional groups within BioMarin

Requirements

• Up to 6 years of as a medical writer in the pharmaceutical industry – OR - at least 10 years of medical or scientific writing experience as a primary job responsibility.
• Medical Writing: Experience writing, reviewing, or editing protocols and clinical study reports required. Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred. Experience writing, reviewing, or editing regulatory briefing books preferred. 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. Advanced applied knowledge of basic clinical laboratory tests. Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
• 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.
• Regulatory: Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports). Prior familiarity with standard eCTD IND/NDA work, including:
• Project Management: Capable of working on multiple tasks and shifting priorities. Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation. Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross-functional conflicts. Good conflict management skills. Motivated and shows initiative. Detail oriented.
• 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; intermediate to advanced presentation skills.