Overview
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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.
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.)
* Drafts and edits documents used in the preparation of regulatory filings (e.g., briefing books, eCTD Module 2/Module 5 clinical or integrated summaries)
* 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
* Represents Global Medical Writing at cross-functional team meetings (e.g., study team, development team, other subteams)
* Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met
* Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
* Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
* 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
Education and Experience
Education
Bachelor’s or higher degree required; scientific focus desirable. Minimum requirement: Experience in medical 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.
Experience
State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
Relevant Experience
* Up to 6 years of as a medical writer in the pharmaceutical industry
* At least 10 years of medical or scientific writing experience as a primary job responsibility
Clinical Studies
* Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets
* Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection
* Intermediate to advanced 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, integrated results reporting
* Direct experience with documentation in all phases of drug development
Medical Writing
* Experience writing, reviewing, or editing protocols and clinical study reports required
* Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred
* Experience writing, reviewing, or editing regulatory briefing books preferred
* Advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents
* Ability to interpret and create complex tabular and graphical clinical data presentations
* Advanced applied knowledge of basic clinical laboratory tests
* Understanding of coding dictionaries (MedDRA, WHO Drug)
Computer/office equipment Skills
* Proficient in Microsoft Word (including templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint
* Experience using document management software (e.g., LiveLink, SharePoint, Veeva)
* Experienced with scanners, printers, and copiers
Regulatory
* Intermediate to advanced knowledge of regulatory requirements and guidances for standalone regulatory documents (e.g., protocols, investigator brochures, and clinical study reports)
* Familiar with standard eCTD IND/NDA work, including Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format; Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
Project Management
* Capable of working on multiple tasks and shifting priorities
* Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing document review and comment adjudication stages
* Capable of representing Global Medical Writing at cross-functional meetings and resolving cross-functional conflicts
* Good conflict management skills; motivated, initiative, and detail-oriented
Communication
* Well-organized, concise and clear written and verbal communication
* Ability to translate complex scientific concepts into clear, regulatory-compliant text
* Effective at presenting writing principles to varied audiences; intermediate to advanced presentation skills
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.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Science
Industries
* Biotechnology Research and Pharmaceutical Manufacturing
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