Job Description

Medical Writer 1

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. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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

Fulfills one of the following:

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.

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