Senior Medical Writer

Role Summary

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
• Other tasks as assigned.

Qualifications

• Required: Experience in medical writing.
• Preferred: Evidence of medical writing career development (eg, AMWA certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association).
• Relevant Experience: Fulfills one of the following: 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.

Skills

• 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.
• Clinical Concepts: Intermediate to advanced understanding of nonclinical development, CMC, PK, PD, and antibody detection.
• Medical Writing: Experience writing, reviewing, or editing protocols and clinical study reports; experience with INDs, BLA/NDAs, PBRERs, DSURs, PAERs; regulatory briefing books; and ability to interpret and present complex data; understanding coding dictionaries.
• Computer/Office Skills: Proficient in Word, Excel, Acrobat, MS Project/Project Server, and PowerPoint; experience with document management software (LiveLink, SharePoint, Veeva).
• Regulatory: Knowledge of regulatory requirements and guidances for standalone regulatory documents and eCTD work (IND/NDA modules 2, 3, 4, 5; ISS/ISE).
• Project Management: Ability to manage multiple tasks, lead cross-functional teams, manage timelines, and resolve conflicts; strong organizational skills.
• Communication: Clear written and verbal communication; ability to translate complex scientific concepts into regulatory text; effective presentation skills.

Education

• Bachelor’s or higher degree required; scientific focus desirable.