Medical Writer in London

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. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science.

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.

• 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.).
• 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.

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.

• 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, e.g., American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

• Up to 2 years as a medical writer in the pharmaceutical industry.
• At least 5 years of medical or scientific writing experience as a primary job responsibility.
• Familiar with drug development process (discovery to market).
• Basic understanding of biostatistical and clinical research concepts.
• Basic applied knowledge of documentation required for the conduct of clinical studies, protocol design, and study results reporting.
• Experience writing, reviewing, or editing protocols and clinical study reports preferred.

• Proficient in Microsoft Word, Excel, Adobe Acrobat, and PowerPoint.
• Familiar with document management software (e.g., LiveLink, SharePoint, Veeva).

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

• Capable of working on multiple tasks and shifting priorities.
• Good conflict management skills.
• Motivated and shows initiative.
• Detail oriented.

• Capable of well organized, concise and clear written and verbal communication.
• Effective at explaining writing principles to a varied audience both in individual and group settings.

Please note this role is a hybrid role with attendance on site in our London office required for a minimum of 2 days per week. This role is not a remote role.

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