Medical Writer

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

About Worldwide Research and Development: From research and discovery to post-market clinical development, our WWRD 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 genetic diseases.

The Medical Writer applies basic to intermediate 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. This position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals.

Responsibilities:

• Aids in managing study team participation in the preparation of documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes.
• 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 Global Medical Writing.
• Works effectively with cross-functional groups within BioMarin.
• Other tasks as assigned.

Relevant Experience:

• Minimum 2 years as a medical writer in the pharmaceutical industry or minimum 5 years of medical or scientific writing experience as a primary job responsibility.
• Familiar with drug development process (discovery to market).
• Understanding of biostatistical and clinical research concepts.
• Applied knowledge of documentation required for the conduct of clinical studies, protocol design, study results reporting, and writing high-quality documents that support corporate goals and objectives.
• Experience writing, reviewing, or editing protocols and clinical study reports preferred.
• Basic applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents.
• Ability to interpret basic tabular and graphical clinical data presentations.
• Basic to intermediate applied knowledge of basic clinical laboratory tests and understanding of coding dictionaries.

Regulatory:

• Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents.

Project Management:

• Capable of working on multiple tasks and shifting priorities.
• 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; basic presentation skills.

Education:

• Bachelor’s or higher degree preferred; scientific focus desirable.
• Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.
• Evidence of medical writing career development desirable.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.