Medical Writer in London

Who We Are 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. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.

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.

Scope: This position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase 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.

• Aids in managing 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.
• 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.

Relevant Experience: Fulfils one of the following:

• Minimum 2 years as a medical writer in the pharmaceutical industry.
• Minimum 5 years of medical or scientific writing experience as a primary job responsibility.

Clinical Studies:

• 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, and study results reporting.

Medical Writing:

• 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.
• Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).

Regulatory:

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

Additional skills:

• 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. Effective at explaining writing principles to a varied audience.

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.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.