Principal Clinical Medical Writer

Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development
From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.
SUMMARY DESCRIPTION:

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 BioMarin 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. The Principal Clinical Medical Writer has functional oversight responsibilities for medical writing staff and for the medical writing requirements for clinical development programs, including authoring/editing documents.
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 understandin