Medical Writer

Medical Writer

Bio Marin Pharmaceutical Inc.

Join us as a Medical Writer and help translate genetic discoveries into new medicines that advance the future of human health. Bio Marin is a global biotechnology company that relentlessly pursues bold science from discovery to market.

Founded in 1997, Bio Marin applies scientific expertise in genetics and molecular biology to develop transformative medicines for patients with significant unmet medical need. Our distinctive approach to drug discovery has produced a diverse pipeline of commercial, clinical and preclinical candidates, many of which are first‑to‑market or provide substantial benefits over existing options.

We work from research and discovery through to post‑market clinical development, supporting all bench and clinical research activities. Our teams develop first‑in‑class and best‑in‑class therapeutics that provide meaningful advances to patients living with genetic diseases.

• Drafts and edits documents used in conducting and reporting 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 (investigator’s brochures, periodic safety reports, DSURs, etc.).
• Aids in managing study team participation in the preparation of such documents, including calling and 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, 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 Bio Marin.
• Other tasks as assigned.

This position will help develop the medical‑writing function in alignment with clinical development and organizational goals. Hiring a full‑time employee will reduce writing‑related CRO and contractor costs, increase productivity, and realize efficiencies and consistent documentation quality across programs.

• Preferred:
  Bachelor’s or higher degree with a scientific focus.
• Minimum:
  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 the drug development process from discovery to market.
• Basic understanding of biostatistical and clinical research concepts.
• Basic applied knowledge of documentation required for the conduct of clinical studies.
• Basic knowledge of protocol design (objectives, efficacy and safety endpoints, procedures for collecting and reporting adverse events and serious adverse events).
• Basic knowledge of study results reporting.

• 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 (e.g., Schedule of Events).
• Basic to intermediate applied knowledge of basic clinical laboratory tests.
• Basic understanding of coding dictionary concepts (MedDRA, WHO Drug).

• Proficient in Microsoft Word (including templates), Excel, Adobe Acrobat and PowerPoint.
• Familiar with document management software (Live Link,…