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. 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.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.


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.

 

Hybrid (1-2 days in office to align with company policy). Seeking candidates who are regulatory medical writers (not Medical Communication) The Contract Medical Writer applies advanced 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 for submissions including CTDs and RtQs
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)
• Manages 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
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Works effectively with cross-functional groups within BioMarin  Other tasks as assigned.
• SUPERVISOR RESPONSIBILITY None.CONTACTSClinical Medical Writing, Biostatistics, Clinical Data Management, Statistical Programming, Clinical Operations, Medical Affairs, Medical Directors, Regulatory Affairs, Legal, Commercial, Pharmacology/Toxicology, Corporate Compliance, Project management, Pharmacovigilance. EQUIPMENTAccess to corporate computer network, production computing environment, and MS Windows software.

 

Skills

 Fulfills one of the following:

• Medical writer in the pharmaceutical industry
• Medical or scientific writing experience as a primary job responsibility

Skill and Experience: At least 5 years experience required

• Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
• Familiar with clinical study data collection and results reporting.  Previous protocol development experience required.
• Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
• Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.