Overview

Join to apply for the Medical Writer role at BioMarin Pharmaceutical Inc.

The Medical Writer 1 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.

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.)
• 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
• Other tasks as assigned

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.

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

Experience

Relevant Experience

• 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

Clinical Studies

• 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 (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)
• 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 (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content
• Ability to interpret basic tabular and graphical clinical data presentations
• Ability to create basic tables using AMA style (eg, Schedule of Events)
• Basic to intermediate applied knowledge of basic clinical laboratory tests
• Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)

Computer/Office Equipment Skills

• Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint
• Familiar with document management software (eg, LiveLink, SharePoint, Veeva)
• Experienced with scanners, printers, and copiers

Regulatory

• Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports)

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

Location

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.

Other

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. Equal Opportunity Employer/Veterans/Disabled. 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.

Seniorities and Employment Type

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Science
• Industries: Biotechnology Research and Pharmaceutical Manufacturing

Note: This refined description removes extraneous postings and keeps the core job information intact.